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Contract & Third Party Manufacturing

Pharma Contract & Third Party Manufacturing, designed for businesses looking to expand their brand portfolio without owning a manufacturing facility:- 

 

  • Third Party Manufacturing (TPM): You (the marketer) outsource manufacturing to a licensed manufacturer under your brand name and specifications.

 

  • Contract Manufacturing (CM): A formal agreement where a manufacturer produces products for multiple parties, usually under defined contracts with strict SLAs and custom formulations

🔁 2. Bioburg Process Works (Step-by-Step)

1. Product Finalization                             :         Molecule, dosage form, strength, packaging.

2. Manufacturer Selection                       :         WHO-GMP certified preferred.

3. Quotation & MOQ                                 :         Pricing, Minimum Order Quantity.

4. Agreement Signing                              :         Legal and regulatory agreement.

5. Product Dossier                                   :         Brand name, composition, pack style.

6. Design & Approval                               :         Label/artwork per D&C Act

7. Manufacturing & QA                            :         As per GMP Norms.

8. Dispatch & Billing                                :         With Form 16/Form 20B/Form 21B copy.

9. Marketing Launch                                :          Product promotion by your team.

 

📜 3. Legal & Regulatory Requirements :

📄 Documents Required :

(i0 Company PAN & GST, (ii) Drug License (Form 20B & 21B or Wholesale License), (iii) Brand Name Ownership Declaration, (iv) Agreement with Manufacturer

🧪 Manufacturer Compliance:

* WHO-GMP / ISO Certifications, * Valid Manufacturing License, * Pollution NOC, Fire NOC (if required), * QA/QC team and analytical report, * Batch-wise COA (Certificate of Analysis).

 

📜 Product Types :

Tablets/Capsules                                     :          Antibiotics, Multivitamins.

Syrups/Suspensions                              :           Pediatric, Digestive..

Injectables                                               :           Cephalosporins, Painkillers.

Ointments/Creams                                  :           Antifungal, Cosmetic.

Nutraceuticals                                         :            Protein powders, Softgels.

Ayurvedic/Herbal                                    :            Churnas, Syrups, Oils.

 

💰 5. Cost Structure in Third Party Manufacturing

Product Manufacturing Cost                 :            Depends on API, excipients, formulation.

Packaging Material Cost                       :            Outer box, label, foil, bottle, carton.

Design & Plate Charges                        :           One-time cost for new brand (~₹2,000–₹5,000)

GST & Freight                                        :            12–18% depending on the product.

Testing Charges (if extra)                     :             ₹500–₹2,000 per batch.

MOQ                                                       :             Often 500–1,000 units per SKU.

 

📑 6. Agreement Clauses :

Confidentiality                                        :            To protect formula/brand details

Quality Assurance                                 :            Must meet pharmacopeia standards.

Delivery Timeframe                               :           Usually 30–45 days post order.

Liability for Complaints                        :            Who handles product recall or AE.

Termination                                           :            Conditions to end the partnership.

IP Rights                                               :             Brand ownership remains with marketer.

 

📊 7. Key Performance Indicators (KPIs)

Batch Rejection Rate                          :             <2%

On-time Delivery                                 :              >95%

Quality Compliance                            :              100% with specs

Shelf Life Offered                               :               Minimum 24–36 months

Labeling Errors                                  :               Zero tolerance.

 

🧠 8. Benefits of Third Party Manufacturing

Low Investment                                 :               No manufacturing plant needed

Wide Product Range                         :              Can launch multiple SKUs

Focus on Marketing                          :              Leave production to experts

Faster Time to Market                      :              With existing manufacturers

Flexibility                                          :              Can switch manufacturers as needed

Pharma Franchise Provided

PCD PHARMA FRANCHISE 

PCD (Propaganda Cum Distribution) Pharma Franchise is a business model in the pharmaceutical industry that allows individuals or small companies to market and distribute pharmaceutical products under the brand name of a larger pharma company. It is a low-investment and high-opportunity model, popular in India and other developing markets.

PCD Pharma Franchise refers to authorization given by a pharmaceutical company to an individual or distributor (franchisee) to use the company’s brand name, products, and promotional materials for marketing and distribution in a defined territory.

The term “Propaganda cum Distribution” means:

  • Propaganda – Promotion and marketing of pharmaceutical products.

  • Distribution – Supplying products to medical professionals, retailers, and institutions.

🧾 PCD Pharma Franchise Works

  1. Pharma Company (Franchisor) provides:

    • Product list

    • MR packs / promotional materials

    • Price list & rates

    • Monopoly rights (area-specific)

    • Supply of medicines

  2. Franchise Partner (Franchisee) handles:

    • Doctor visits & product marketing

    • Order generation

    • Distribution in assigned territory

    • Local relationship management

✅ Benefits of PCD Pharma Franchise : 

Benefits Description
Low Investment Ideal for new entrepreneurs with small capital.
Monopoly Rights Exclusive rights for a specific area or district.
High Return on Investment (ROI) Profit margins are good depending on sales volume.
Established Brand Support Use of reputed company name and quality products.
Marketing Materials Free promotional tools: Visual aids, MR bags, pens, samples, etc.
Own Business Freedom to operate independently.

 

📦 Product Range Offered

Bioburg Lifesciences PCD Pharma Companies offer a wide range of products including:

  • Tablets, Capsules

  • Injections

  • Syrups, Suspensions

  • Ointments, Creams

  • Ayurvedic/Herbal Medicines

  • Nutraceuticals

  • Eye/Ear drops

  • Pediatric & Gynae Range

  • Critical Care & Cardiac Diabetic Range

 

📝 Documents Required

  • Drug License (Retail or Wholesale)

  • GST Registration

  • PAN Card & Aadhaar Card

  • Experience in Pharma Sales (preferred but not mandatory)

 

🔍 Choosing a Good PCD Company

  • ISO/GMP/WHO certifications

  • Wide product portfolio

  • Timely delivery & stock availability

  • Transparent pricing & policies

  • Monopoly rights confirmation

  • Good market reputation

💼 Who Can Apply for PCD Franchise in Bioburg?

  • Pharma Sales Professionals

  • Medical Representatives

  • Distributors / Wholesalers / Retailers

  • Entrepreneurs seeking pharma business entry

If you want, I can also help you:

  • Draft a proposal to apply for a PCD Franchise

  • Compare top PCD companies in India

  • Create a business plan for your area

 

FRANCHISE AGREEMENT

This is the franchise agreement between Bioburg Lifesciences with _______________. Bioburg Lifesciences, Plot No : A-53, FF/SF, Ramapark, Uttam Nagar, New Delhi-110059 is Supplier of this Agreement Represented By its ______________________________________________ .  is a Distributer of this Agreement which is represented By _______________________________________________________________________.

This Agreement is made by date _________________ and it’s Valid for 10 years and shall be renewed at will of both parties. In case of any Dispute Between both parties, the Arbitrator shall be appointed at New Delhi by mutual agreement of both parties to settle the matter. The rates would be as per enclosed list subject to change as per fluctuation in currency or any overhead.

Duties & Responsibility of Each Parties:

Bioburg Lifesciences :-

         Bioburg Lifesciences Pharma is desirous of Exporting / Marketing Their Finished Pharmaceutical Products, manufactured in India and of Indian Origin for the Indian Markets.

         Bioburg Lifesciences Pharma will be paid to _______________________ all expenses of Registration & proforma fee in a three Purchasing Order.

         Bioburg Lifesciences Pharma will be paid a salary of one Manager Monthly and Literature, Samples and other Small Promotional Materials.

         Bioburg Lifesciences Pharma is Responsible of Prepare Stock to Submit to ________________________________________________________________________ and the Rent or other Charges & responsibility of this order from Company to Delhi is on Bioburg Lifesciences pharma.

         Bioburg Lifesciences Pharma is responsible of any Kind of Claims related to Quality of products in the time of Quality Control at Delhi.

         Bioburg Lifesciences Pharma will Supply to ______________________________ all technical Support and Documents for health.

         Bioburg Lifesciences Pharma Can Not Deal with any other person for _______________________________________.  Tell the contract is Valid.

         The Orders will be Prepare from 15 Days to 20 Days.

 

Witness:                                                                                                                                                          (Signature of Authorise Signatory)

1.

2.

Market Research & Analysis

Bioburg Research Lab :

Pharma Market Research & Analysis is the process of gathering, evaluating, and interpreting information related to the pharmaceutical industry, with the goal of making informed strategic decisions. Here's a detailed overview of how it's conducted, key focus areas, methodologies, and current trends.

Pharma Market Research involves studying:

  • Current market size & growth rate

  • Competitor performance

  • Consumer (patient/doctor/pharmacist) behavior

  • Regulatory environment

  • Product lifecycle and innovation

  • Market entry and expansion opportunities

Bioburg Research & Analysis :

🧪 Key Segments in Pharma Market Analysis

  1. Therapeutic Areas
    • Oncology

    • Cardiology

    • Neurology

    • Infectious Diseases

    • Diabetes and Metabolic Disorders

    • Respiratory Disorders

  2. Drug Type
    • Branded drugs

    • Generic drugs

    • Biosimilars

    • OTC products

  3. Formulation
    • Tablets/Capsules

    • Injections/Infusions

    • Syrups/Suspensions

    • Topicals

    • Inhalers

  4. Market Type
    • Domestic (local/regional)

    • International (global exports)

 

📊 Core Market Research Methods

1. Primary Research

  • Surveys with doctors, pharmacists, patients

  • Focus groups

  • Interviews with key opinion leaders (KOLs)

  • Field visits to hospitals and pharmacies

2. Secondary Research

  • Market reports (IQVIA, Frost & Sullivan, Grand View Research)

  • Government health data (NMPA, CDSCO, FDA, WHO)

  • Sales data and import/export records

  • Competitor websites, publications, and investor reports

3. Data Analytics

  • SWOT & PESTLE Analysis

  • Market Share Analysis

  • Growth forecasting (CAGR)

  • Pipeline & patent analysis

Product Analysis, Laboratory & Registration

Bioburg Laboratory :

Pharma Product Analysis, Laboratory Process, and Product Registration, covering the essential stages of bringing a pharmaceutical product to market—from lab testing to regulatory approval.

🔍 1. Pharma Product Analysis

Objective: Ensure the product meets safety, efficacy, quality, and compliance standards before launch.

✅ Key Components of Product Analysis:

Area

Description

API & Excipients

Identification, purity, potency, and source of ingredients

Stability Studies

Tests under ICH conditions (temperature/humidity) for shelf life

Bioavailability/Bioequivalence (BA/BE)

To compare absorption levels (especially for generics)

Dissolution & Disintegration

To evaluate how fast the drug releases in the body

Impurity Profiling

Detect and quantify degradation products

Microbiological Tests

Especially for injectables, eye drops, or suspensions

Packaging Compatibility

Interaction of formulation with container-closure systems

Product Analysis Reports :

⚙️ Analytical Techniques:

  • HPLC (High-Performance Liquid Chromatography)

  • GC (Gas Chromatography)

  • UV/Vis Spectroscopy

  • FTIR (Fourier Transform Infrared Spectroscopy)

  • Mass Spectrometry

  • Titration (manual & potentiometric)

 

🧪 2. Pharmaceutical Laboratory Setup & Workflow

🏢 Types of Labs:

  1. R&D Labs – Formulation development, stability testing

  2. QC Labs – Batch-wise quality control testing

  3. QA Labs – Documentation and compliance checks

  4. Microbiology Labs – Sterility, endotoxin, and microbial limit testing

📋 Typical Laboratory Workflow:

  1. Sample Receipt

  2. Batch Coding & Documentation

  3. Testing (chemical/microbiological)

  4. Data Logging

  5. Report Generation (COA - Certificate of Analysis)

  6. Release/Reject Decision by QA

🧼 Lab Compliance:

  • cGMP (Current Good Manufacturing Practice)

  • GLP (Good Laboratory Practice)

  • 21 CFR Part 11 (for electronic records in US FDA audits)

  • NABL Accreditation (India)

 

📝 3. Product Registration Process

📍 In India (CDSCO/DCGI)

A. For Manufacturing License (New Drug/Formulation)

  1. File Form 44 with relevant dossiers

  2. Submit CTD (Common Technical Document)

    • Module 1 – Regional information (cover letter, legal docs)

    • Module 2-5 – Quality, safety, efficacy, non-clinical, and clinical trial data

  3. Stability & BA/BE studies (if needed)

  4. Labeling & packaging compliance (Schedule M, U, Y)

  5. Review & approval from DCGI (Drug Controller General of India)

B. For Import License

  1. Submit Form 40

  2. Import Registration Certificate (Form 41)

  3. Dossiers including:

    • Free Sale Certificate from country of origin

    • Manufacturing site GMP certificate

    • Stability data

    • Product samples

    • Local agent representation (for foreign companies)

 

🌍 In International Markets

Region

Authority

Notes

USA

US FDA

ANDA (for generics), NDA (for new drugs)

EU

EMA

Centralised, DCP, or MRP pathways

UK

MHRA

Post-Brexit, separate from EMA

WHO

PQ (Prequalification)

Needed for UN or NGO tenders

Africa

NAFDAC, SAHPRA, PPB

Each country has its own regulator

 

✅ Summary Checklist

Step

Action

✔️ Product R&D

Formulation, Preclinical & Clinical studies

✔️ Analytical Testing

In-house or third-party labs

✔️ Regulatory Dossier

CTD/eCTD submission

✔️ Product Registration

CDSCO/FDA/EMA etc.

✔️ Launch Preparation

Packaging, distribution, marketing

Cost Planning & Analysis

Pharma Products Cost Planning & Analysis is a crucial part of pharmaceutical business management. It ensures that products are priced profitably while remaining competitive and compliant with regulatory norms. Here's a complete breakdown : 

💰 1. Cost Planning & Analysis?

It involves estimating, controlling, and analyzing all the costs associated with:

  • Developing

  • Manufacturing

  • Marketing

  • Distributing

🧮 2. Key Components of Cost Structure in Bioburg

Cost Category

Includes

R&D Cost

Discovery, preclinical, clinical trials (Phases I–III)

API Cost

Active Pharmaceutical Ingredient (sourcing or synthesis)

Excipient & Packaging

Inactive ingredients, blisters, bottles, labels

Manufacturing Cost

Equipment, labor, energy, water, maintenance

Testing & QA/QC

Laboratory costs, documentation, batch release

Regulatory Compliance

Dossier preparation, registration fees, audits

Marketing & Distribution

Promotional material, field staff, logistics

Overhead Costs

Rent, admin, utilities, depreciation

 

🧾 3. Cost Planning Process (Step-by-Step)

A. Product Cost Estimation

  1. Bill of Materials (BOM):
    • List and calculate the quantity and cost of all components (API, excipients, packaging).
  2. Per Batch Costing:
    • Based on batch size (e.g., 100,000 tablets).
  3. Unit Costing:
    • Divide total cost by units per batch (e.g., per tablet, capsule, vial).

B. Operational Cost Planning

  • Labor cost per batch

  • Energy/fuel consumption

  • Equipment depreciation

  • Waste management & compliance

C. Regulatory & Marketing Cost

  • Cost of dossier submission, BA/BE studies, promotional inputs. 

  • Cost recovery planned over expected product lifecycle (3–7 years)

 

📊 4. Cost Breakdown per Tablet (Generic)

Component

Cost (INR)

API (e.g., Paracetamol)

0.40

Excipients & Coating

0.15

Packaging (blister, foil)

0.20

Manufacturing (labor, power)

0.10

QA/QC Testing

0.05

Admin/Overhead

0.10

Total Cost/Tablet

₹1.00

Suggested selling price: ₹1.80 – ₹2.50 (with margin)

 

🧠 5. Cost Analysis Tools

Tool

Use

Standard Costing

Set predefined cost for comparison with actual

Activity-Based Costing (ABC)

Allocates indirect costs based on actual usage

Break-even Analysis

Calculates volume needed to cover costs

Contribution Margin

Selling Price – Variable Cost

 

📈 6. Profitability Analysis

📌 Metrics:

  • Gross Margin % = (Selling Price - COGS) / Selling Price × 100

  • ROI = (Net Profit / Total Investment) × 100

  • Payback Period = Time to recover investment

NPV & IRR (for large R&D or facility investments)

 

🧾 7. Cost Control & Optimization Strategies

Area

Strategy

API

Source from low-cost countries or develop in-house synthesis

Packaging

Bulk procurement, lightweight materials

Manufacturing

Automate processes, reduce batch failures

Marketing

Focused doctor segmentation, digital promotion

Logistics

Consolidated shipping, better distributor terms

 

📘 8. Regulatory Pricing in India (DPCO)

  • National Pharmaceutical Pricing Authority (NPPA) controls prices of essential drugs under DPCO.

  • Ceiling Price: For drugs listed in NLEM (National List of Essential Medicines)

  • Companies must comply with:

    • Form-V: For new drug launch

    • Form-I: For price revision

 

📦 9. Export Cost Planning

  • Regulatory dossier cost (e.g., EU/US compliance)

  • Freight & insurance

  • Customs duties

  • Country-specific registration & marketing

 

✅ Summary Checklist

Task

Done?

API & Raw Material Costing ✔

 

Batch & Unit Costing ✔

 

Regulatory & Dossier Cost Estimation ✔

 

Sales & Marketing Budget ✔

 

Break-even & Margin Analysis ✔

 

DPCO/NPPA Compliance Check ✔

 

Business Strategy & Consumer Insights

Pharma Business Strategy & Consumer Insights, covering how pharmaceutical companies can compete effectively while meeting the needs of doctors, patients, pharmacists, and regulators.

🧠 1. Pharma Business Strategy: Overview

Pharma strategy combines scientific innovation, regulatory compliance, and commercial intelligence to create sustainable growth.

🎯 Core Strategic Pillars

Pillar

Description

Product Portfolio Strategy

Focus on niche or high-demand therapeutic segments (e.g., oncology, diabetes, CNS)

Market Access Strategy

Get product into hospitals, pharmacies, and public health systems

Pricing & Reimbursement Strategy

Align with DPCO (India), insurance, and public sector pricing

Geographic Expansion

Domestic vs. international markets (regulated vs. semi-regulated)

Regulatory Compliance

Ensure dossier quality, audits, pharmacovigilance

Digital Transformation

E-detailing, CRM for MR (Medical Rep), online marketing

📈 2. Go-to-Market (GTM) Strategy

🏥 Prescription-driven Products (Rx)

  1. Target Physicians:

    • Specialists relevant to the drug (cardiologists, diabetologists)

    • CME (Continuing Medical Education) sponsorships

    • KOL (Key Opinion Leader) engagement

  2. Medical Representatives (MRs):
    • Route planning, sample distribution, brand reminders

    • CRM tools (like C-Square, Salesforce Health Cloud)

  3. Distributor/Retailer Strategy:
    • Trade schemes, credit terms

    • Local stockist network (CFAs and SS partners)

 

🏪 OTC Products (Non-Rx)

  • Mass advertising (TV, YouTube, hoardings)

  • Retail promotions (Buy 1 Get 1, display offers)

  • E-commerce channels (1mg, Netmeds, PharmEasy)

 

📊 3. Consumer Insights in Pharma

Understanding the needs and behaviors of patients, doctors, and pharmacists is essential.

👩‍⚕️ Doctors’ Insights

  • Prefer evidence-based prescribing

  • Value safety and efficacy over price

  • Loyal to companies with good support and prompt service

  • Attuned to peer recommendations and CME content

🧑‍🔬 Pharmacists’ Insights

  • Push high-margin generics

  • Prioritize companies with consistent supply

  • Influenced by incentives and promotional support

👨‍⚕️ Patient Insights

  • Cost-sensitive, especially in India

  • Rely on doctor’s or pharmacist’s recommendation

  • Increasing awareness from online health portals

 

🧪 4. Market Segmentation & Positioning

Segmentation Criteria

  • By Therapy             :         e.g., Anti-infective, Cardio, Neuro, Gastro

  • By Geography        :         Urban vs. rural market

  • By Channel             :         Hospital, pharmacy retail, online B2C

  • By Class                 :          Ethical vs. OTC

Positioning Strategies

  • Quality-focused: “Same efficacy as MNC brands”

  • Affordable: “Low-cost therapy for all”

  • Innovation-driven: “Unique molecule/formulation”

  • Specialist-specific: “Trusted by dermatologists”

 

💹 5. Competitive Strategies

Strategy

Details

Brand Differentiation

Different pack design, faster onset claims, USPs

First Mover Advantage

Launch new combinations or NDDS (novel delivery systems)

Therapeutic Leadership

Dominate a specific segment (e.g., 5 brands in gastro)

Strategic Alliances

Licensing, joint ventures, or tech transfers

 

📱 6. Digital Strategy

  • MR e-Detailing: Tablets for product presentations

  • Doctor engagement: Webinars, emailers, YouTube videos

  • Online pharmacies: Partnering for digital shelf space

  • Telemedicine: Partner with platforms to increase drug visibility

 

🏛️ 7. Public & Institutional Market Strategy

  • Tender participation (CGHS, Railways, State Health Missions)
  • WHO-GMP certification for UN or NGO procurement
  • Focus on volume-based pricing models

 

📋 8. KPIs for Business Success

KPI

Purpose

Rx Generation

Number of prescriptions per doctor

Brand-wise Sales

Monthly/quarterly sales reports

Retail Offtake

Movement from retailers to end customer

Profit per Brand

Net margin per SKU

Territory Coverage

% of active doctors and chemists visited

 

🧾 9. Challenges & Mitigation

Challenge

Solution

Doctor reluctance

Focus on KOL support and scientific credibility

Retailer push for high-margin products

Ensure competitive margin and stock availability

Regulatory hurdles

Strong QA/QC and legal support

Brand substitution

Strong recall through branding and awareness

 

✅ Summary

A successful pharma business strategy must:

  • Balance compliance, innovation, and affordability

  • Target the right consumer (doctor/patient/pharmacist)

  • Leverage data and digital for growth

  • Align product portfolio with therapeutic trends

Brand Building & Management

Pharma Brand Building & Management is a specialized strategy focused on creating trust, recall, and differentiation for pharmaceutical products in the minds of doctors, patients, and pharmacists. In a market where hundreds of similar brands compete, strong branding ensures consistent prescriptions, loyalty, and long-term growth.

🌟 1. What is Pharma Brand Building?

It is the process of developing a unique identity, image, and positioning for a pharmaceutical product to:

  • Win the trust of healthcare professionals (HCPs)
  • Ensure repeat prescriptions
  • Stand out from generic competitors
  • Build long-term brand equity

🧱 2. Pillars of a Strong Pharma Brand

Pillar

Description

Therapeutic Relevance

Targeting a real, well-understood medical need

Scientific Backing

Clear evidence of efficacy and safety

Visual Identity

Consistent and appealing brand name, logo, design

Promotional Strategy

MR detailing, CME, doctor engagement, packaging

Emotional Connect

Association with care, relief, or innovation

Recall Value

Easy to remember for prescribers and retailers

 

🧪 3. Pharma Brand Lifecycle

  1. Pre-Launch Phase
    • Market research
    • Competitor analysis
    • Finalizing brand name and messaging
    • Designing product, packaging, and promotional content
  2. Launch Phase
    • Medical rep training
    • Doctor engagement strategy (gifts, samples, CMEs)
    • Visual Aid (VA) and LBLs (Leave Behind Literatures)
    • Retailer push and stock availability
  3. Post-Launch Growth
    • Collect Rx feedback
    • Increase detailing frequency
    • Run doctor loyalty campaigns
    • Reinforce brand USPs (Unique Selling Points)
  4. Maturity & Retention
    • Brand reminders (calendars, pens, bags)
    • Scientific updates
    • Line extensions (e.g., +DSR, +SR, syrup form)

 

🧠 4. Brand Positioning Strategy

Strategy Type

Example

Science-Driven

"Clinically proven to reduce BP in 3 days"

Affordability-Driven

"Best price for diabetes control"

Safety-Driven

"Lowest GI side effects in class"

Innovation-Focused

"First multilayer release tablet in India"

Emotionally Driven

"Care you can trust for your child’s fever"

 

🎯 5. Branding Elements in Bioburg

Element

Role

Brand Name

Easy to pronounce, recall, and prescribe

Visual Aid (VA)

Structured tool for MR to present product benefits

LBL (Leave Behind Literature)

Reminder of brand USPs

Catchy Tagline

E.g., "Fast relief, full recovery"

Packaging

Distinctive colors, icons, and secure design

Doctor Gifts/Reminders

Branded pens, pads, digital gadgets, etc.

Digital Presence

Emailers, doctor webinars, e-detailing apps

 

📈 6. Performance Tracking Metrics (Brand KPIs)

KPI

Description

Rx Count

Total number of prescriptions per month

Doctor Coverage %

% of target doctors visited regularly

Brand Recall Score

Brand mention in surveys with doctors/pharmacists

MR Productivity

Avg. Rx per visit

Retail Offtake

Movement of product from chemist to patient

Market Share

% share in its molecule/segment

 

🛠️ 7. Brand Management Strategies

A. For New Brands

  • Launch with a strong value proposition
  • Focus on a niche therapeutic class
  • Leverage digital channels and KOLs

B. For Growing Brands

  • Expand indications or line extensions
  • Reinforce clinical benefits in CMEs
  • Introduce loyalty/reward programs for prescribers

C. For Mature Brands

  • Run “legacy campaigns”
  • Leverage emotional stories (e.g., patient success stories)
  • Offer combo packs or brand extensions (e.g., DSR, Plus)

 

🔄 8. Common Mistakes in Pharma Branding

Mistake

Risk

Generic sounding names

Easy substitution by chemists

Over-reliance on MR pitch

No direct HCP/digital engagement

Poor packaging

Damaged image or confusion

No regular brand updates

Doctors forget or stop prescribing

No retail connect

Low offtake even with good Rx base

 

🧾 9. Sample Brand Building Toolkit

  1. Brand Booklet (USP, clinical proof, MR script)

  2. Visual Aid & LBL

  3. Scientific Monograph (for doctors)

  4. Product Samples

  5. Promotional Gifts (doctor branding tools)

  6. Doctor Campaign Plan (Q1–Q4 targets)

  7. Retailer Scheme Plan

  8. Digital Presentation (e-detailing PDF, emailer)

 

✅ Summary

Pharma brand success = Scientific strength + Doctor trust + Consistent recall

To build and manage a powerful pharma brand:

  • Create a clear identity

  • Communicate evidence-based benefits

  • Support MRs with strong tools

  • Stay top-of-mind for doctors and chemists

Regulatory, Sales & Marketing & Business Intelligence

Pharma Regulatory, Sales & Marketing, and Business Intelligence, tailored for professionals managing pharmaceutical business operations across development, compliance, and growth:

⚖️ 1. Regulatory Affairs in Pharma

Regulatory affairs ensure that pharmaceutical products comply with all legal and scientific requirements before and after market entry.

🔍 Key Functions:

  • Dossier Preparation (CTD/eCTD for domestic and export markets)

  • Drug Registration & Approvals (CDSCO, FDA, EMA, WHO, etc.)

  • BA/BE Studies Coordination (for generics and new combinations)

  • Labeling Compliance (as per Schedule Y, G, H, X, etc.)

  • Renewals & Variations (post-approval changes, license renewals)

  • Audits & Inspections (regulatory agency visits, WHO-GMP audits)

📜 Major Indian Regulatory Bodies:

  • CDSCO – Central Drugs Standard Control Organization

  • DCGI – Drugs Controller General of India

  • NPPA – National Pharmaceutical Pricing Authority

State FDAs – For retail/manufacturing licenses

💼 2. Pharma Sales & Marketing Strategy

Sales and marketing are the backbone of pharma revenue generation. It's a doctor- and chemist-driven model that increasingly includes digital channels.

🧩 Marketing Mix (4Ps in Pharma):

Element

Focus

Product

Therapeutic need, safety, efficacy, dosage form

Price

Cost-based, value-based, NPPA-compliant

Place

Distribution channels (hospital, retail, online)

Promotion

MRs, CMEs, samples, reminders, digital outreach

 

🧠 Strategic Sales Segmentation:

  • Ethical Marketing: Prescription-based via doctors

  • Trade/Generic Marketing: Price-driven, chemist-pushed

  • OTC Products: Public awareness and direct advertising

  • Institutional Sales: Tendering to hospitals, government

🧑‍⚕️ Tools for Sales Growth:

  • Visual Aids (VA) and MR Training

  • CRM Software (e.g., C-Square, SFA, Veeva)

  • Doctor Loyalty Programs

  • Retailer Schemes (Discounts, bonuses)

  • e-Detailing & WhatsApp Marketing

 

📊 3. Business Intelligence (BI)

Business Intelligence involves collecting, analyzing, and interpreting data to make strategic decisions that enhance performance and profitability.

🔍 Sources of BI:

  • Rx Data (from field, IQVIA, Medgis, etc.)

  • Sales Data (MR performance, region-wise sales)

  • Retail Offtake Reports

  • Competitor Activity

  • Market Trends & Forecasting

📈 Key BI Metrics:

Metric

Use

Rx-to-Sales Conversion

Tracks how Rx translates to sales

Doctor Coverage %

Measures field force penetration

Brand-wise Market Share

Position vs. competitors

Secondary Sales Reports (SSR)

Tracks distributor-to-retail flow

Gross Margin & Profitability

Per brand or product

🛠 BI Tools & Dashboards:

  • Excel Dashboards

  • Power BI / Tableau

  • CRM Analytics

  • ERP Reports (Tally Prime, SAP, etc.)

 

📌 4. Integration: Regulatory + Sales + BI

Function

Strategic Use

Regulatory

Ensures product approval and lifecycle compliance

Sales & Marketing

Builds prescription, retail, and patient demand

Business Intelligence

Measures ROI and optimizes strategy

Example Integration:

Use BI data to identify a drop in sales → Check if it's due to regulatory supply delay or competitor promo → Adjust marketing tactics accordingly.

 

🧾 5. Combined Checklist:

Task

Department

Product Dossier (CTD format)

Regulatory

DCGI Form 44 Submission

Regulatory

MR Visual Aid & Samples Ready

Marketing

Doctor Target List Finalized

Sales

Pricing Approval from NPPA (if NLEM)

Regulatory

Primary & Secondary Sales Projections

BI

Launch Campaign + Digital Ads

Marketing

Brand Awareness Survey Post Launch

BI

 

🧠 6. Emerging Trends

Trend

Impact

AI in BI

Predictive analytics for MR targeting

Digital Marketing

Remote detailing, WhatsApp Rx follow-ups

Regulatory Tech (RegTech)

Automated dossier submission, compliance alerts

Data-Driven MR Strategy

Smart segmentation and visit planning

 

✅ Summary

Function

Focus

Regulatory

Safe, legal market entry

Sales & Marketing

Driving prescriptions and purchases

Business Intelligence

Strategic decisions based on real-time data

Customer Care Services

Bioburg Customer Care Services are essential for building long-term trust and loyalty with all stakeholders — doctors, patients, chemists, hospitals, and institutional buyers. In today's competitive and regulated environment, proactive and compliant customer support can significantly enhance brand value and business retention. 

📞 1. What is Pharma Customer Care?

Pharma Customer Care refers to support services provided before, during, and after the sale or prescription of pharmaceutical products, including:

  • Medical information

  • Complaint resolution

  • Product availability updates

  • Pharmacovigilance (AE/ADR reporting)

  • After-sales follow-up (especially B2B)

🧩 2. Key Stakeholders in Customer Support

Stakeholder

Type of Support

Doctors (HCPs)

Medical info, CME invites, prescription support

Patients

Dosage info, side effect queries, affordability help

Retailers/Chemists

Stock availability, scheme clarification

Distributors

Dispatch coordination, invoice/billing issues

Hospitals/Government Buyers

Delivery, compliance, and documentation

 

🛠️ 3. Components of a Good Pharma Customer Care System

✅ A. Medical Inquiry Handling

  • Scientific responses to HCP queries

  • Dose adjustments, contraindications

  • Literature support (monographs, trials)

✅ B. Pharmacovigilance Support

  • Toll-free or online AE/ADR reporting

  • Escalation process to Regulatory/QA team

  • Timely response and follow-up

✅ C. Logistics & Supply Support

  • Real-time product availability

  • Order dispatch tracking

  • Cold chain monitoring for sensitive drugs

✅ D. Complaint Management

  • Product defects (e.g., broken blister, color change)

  • Wrong invoice/supply

  • Delay in delivery

  • Batch recall information

✅ E. Training & Product Info

  • For MR or Chemists — through WhatsApp/e-mail

  • Pictorial leaflets for patients

 

💻 4. Channels for Customer Care

Channel

Use

Toll-Free Helpline

For patients, doctors, chemists

Email Support (medinfo@, care@)

Detailed queries or compliance issues

WhatsApp Support

Instant info, refill support

Web Chat/Chatbot

FAQs, AE reporting, refill tracking

Doctor Portals / Apps

Personalized info, e-samples, support tickets

Mobile CRM for MRs

Instant escalation to head office team

 

📊 5. KPIs to Measure Pharma Customer Care Efficiency

KPI

Target

Response Time

< 24 hours

Issue Resolution Time

< 3 business days

Complaint Closure Rate

> 95%

Customer Satisfaction Score (CSAT)

4.5+ / 5

AE Reporting Compliance

100% within TAT

Repeat Contact Ratio

< 10% (for same issue)

 

🚀 6. Value-Added Customer Services in Pharma

Service

Benefit

Reminder Calls/SMS

Boost patient adherence

Home Delivery Tie-ups

Convenience for chronic patients

Doctor Digital Dashboard

Rx history, brand updates

Patient Education Material

Increase trust and engagement

Online Refill Requests

Ease for both patients and chemists

 

🧠 7. Best Practices

  • Keep FAQs and SOPs ready for common issues

  • Ensure multilingual support for patients across India

  • Train support staff on basic medical terminology

  • Maintain confidentiality and data privacy

  • Integrate feedback collection after each resolution

 

❌ 8. Common Mistakes to Avoid

Mistake

Impact

Ignoring pharmacist queries

Loss of retail trust

Delay in AE response

Regulatory non-compliance

One-size-fits-all reply

Low HCP satisfaction

No follow-up on issues

Reputation damage

Manual tracking only

High error and delay risk

 

✅ Summary

Bioburg Customer Care is not just about solving problems — it’s a strategic tool to build relationships and drive repeat business.

Great Customer Support should be:

  • Responsive

  • Scientifically accurate

  • Regulatory-compliant

  • Patient- and doctor-friendly

  • Tech-enabled

E-Commerce / e-Cart Services / BB-Shop

Bioburg E-Commerce / e-Cart Services / BB-Shop (B2B & B2C Models) — covering platform structure, business models, regulations, and growth opportunities in the digital pharma retail space : 

🛒 1. Bioburg Pharma E-Commerce i.e BB-Shop?

Pharma e-commerce involves the online purchase and delivery of pharmaceutical products, either:

  • B2C (Business to Consumer): Patients buying from platforms like Netmeds, 1mg, PharmEasy.

  • B2B (Business to Business): Chemists, hospitals, or distributors purchasing from a wholesaler or manufacturer (via a BB-Shop).

  • Direct Manufactring / Third Party B2B (Business to Business) :

 

🧩 2. Types of Pharma E-Commerce Models

Model

Description

Example

B2C Marketplace

Connects patients with licensed sellers

1mg, Netmeds

Inventory-led B2C

Operates its own pharmacy and warehouse

Apollo 24/7, Medlife

B2B E-Commerce

Online platform for distributors and chemists

Retailio, RedBook, Netmeds Wholesale

Manufacturer-led BB-Shop

Pharma companies sell directly to stockists/retailers

In-house BB-Shop portal or app

⚙️ 3. Key Features of a Bioburg BB-Shop Portal (B2B)

✅ Functional Modules:

  • Login & KYC Verification (Retailers/Distributors)

  • Product Catalog with Search

  • Discount Schemes & Offers Display

  • Bulk Order Cart Functionality

  • Credit/Debit Management

  • Order Tracking & Invoicing

  • Return & Replacement Workflow

  • Inventory Integration (ERP sync)

📱 Optional Add-ons:

  • Android/iOS App
  • Push notifications for schemes/new launches
  • WhatsApp order support

📦 4. B2C E-Commerce BB_Shop Portal

🧪 Product Categories:

  • Prescription (Rx) medicines

  • OTC (over-the-counter) products

  • Wellness/Supplements

  • Surgical items

  • Ayush / Herbal

🔐 Must-Have Features:

  • E-prescription Upload

  • Doctor Consultation (optional)

  • Location-based Availability

  • Secure Payment Gateway

  • Cold Chain Notification (for insulin, vaccines)

⚖️ 5. Legal & Regulatory Requirements in India

Requirement

Applies To

Valid Drug License (Form 20/21)

All sellers

Pharmacy Council Registration

For consultation

GST Registration

All sellers

E-Prescription Verification

For Rx drugs

IT Act Compliance

Data privacy & digital signatures

CDSCO Registration (Voluntary currently)

For marketplaces

 

📈 6. Growth Benefits of E-Commerce in Pharma

Benefit

Impact

Wider Reach

Serve remote regions

24x7 Order Access

Increases order frequency

Scheme Visibility

Promotes product rotation

Data Collection

Buyer preferences, top SKUs

Stock Optimization

Link with WMS/ERP to avoid shortage

Brand Building

Improve digital brand presence

 

🧠 7. Insights for BB-Shop Owners / Manufacturers

📌 Critical Success Factors:

  • High-speed search and product filters

  • Real-time scheme updates

  • Timely dispatch and delivery tracking

  • Strong after-sales support

📉 Common Mistakes:

  • Unverified retailers placing orders

  • Slow catalog updates

  • Weak backend ERP integration

  • No notification of stock-outs or expiry

 

💼 8. Technical Stack for Bioburg BB-Shop / Pharma e-Cart

Feature

Tech Suggestion

Website Framework

React.pk / Next.pk

Backend

Node.js 

Database

MySQL or MongoDB

Mobile App

Android

Hosting

AWS

Payment Gateway

Razorpay / PayU / PhonePe / Paytm

ERP Integration

Tally/SAP/Odoo API

Analytics

Google Analytics, Mixpanel

 

📊 9. KPIs to Track for E-Commerce

KPI

Target

Cart Conversion Rate

>10% (B2C), >30% (B2B)

Average Order Value (AOV)

₹1500–₹5000

Repeat Customer Rate

>50%

Delivery TAT

<48 hours

Stock Out Rate

<2%

Return Rate

<1.5% (Rx products)

 

🚀 10. Roadmap for BB-Shop Launch (Manufacturer to Chemist)

Phase 1: Setup

  • Finalize product catalog, pricing, and schemes

  • Build website/app

  • Integrate with stock & invoice system

Phase 2: Launch

  • Register top 500 chemists/distributors

  • Run onboarding offers

  • Train sales team to promote BB-Shop

Phase 3: Scale

  • Offer exclusive e-coupons

  • Use WhatsApp push marketing

  • Analyze buyer behavior to promote combos/high-margin SKUs

 

✅ Summary

Pharma e-Commerce + BB-Shop unlocks scale, convenience, and visibility in both B2C and B2B models.

For Manufacturers

Launch BB-Shop to serve Chemists & Hospitals Directly

For Distributors

Use e-cart apps to manage schemes, billing, dispatch

For Consumers

B2B e-commerce / BB-Shop offers Customor + delivery

For Consumers B2C e-commerce / BB-Shop offers patient education + delivery