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Pharma Regulatory & licensing Service


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  • 1. Pharma Regulatory & licensing Service
    A.Vikram Sathish
  • 2.
  • 3. Indian companies have recently focused a lot on R&D in the pharmaceutical sector.
    • Many companies now spend 8% or more of revenues on research.
    • 4. Many pharma companies are now actively targeting international companies for contract research and manufacturing (CRAM) deals.
    • 5. Medicinal chemistry, custom synthesis, and clinical studies are some areas in which Indian firms are pitching and winning new business.
  • 6. The global pharmaceutical outsourcing market was worth USD57.2 billion in 2007.
    It is expected to grow at a CAGR of 10% to reach USD76 billion by 2010.
    Global market for Contract Research and Manufacturing Services
    (CRAMS) in 2007 is USD55.48 bn.
    Out of the total global CRAMS market,
    Contract research wasUSD16.58 bn,
    growing at a CAGR of 13.8% and
    Contract manufacturing was USD38.89 bn
    accounting for themajor share (approximately 68%) of the total global pharmaceutical outsourcing market.
  • 7. Indian pharma outsourcing market
    was valued at USD1.27m in 2007 and is expected to reach USD3.33 bn by 2010, growing at a CAGR of 37.6%.
    The Indian CRAMS market stood at USD1.21 bn in 2007, and is estimated to reach USD3.16 bn by 2010.
  • 8. SCOPE
    Pharmaceutical companies increasingly outsource to third parties to save money, speed up processes and get products into the market quicker.
    Outsourcing allows companies to focus on their core competency areas and expedite the entire process.
    In Asia pacific, large biopharmaceutical companies outsource to their local and regional partners.
    CRO's (Contract Research Organizations) move up the value chain with the desire to serve only few global customers rather than diversify in different areas.
    Additionally, they are slowly converting into SMO's (Site Management Organizations), where protocol development and monitoring takes place in addition to R&D.
  • 9. APIs
    Outsourcing Business Space
    Range of Services
    From Clinical quantities to Commercial scale
  • 10. Business Space
    Discovery Chemistry
    Process R& D
    Pipeline Intermediates
    Matured Intermediates
    Pipeline API’s
    Matured API’s
    Dosage Development
    Commercial Drug Product
    Discovery Chemistry
    Process R& D
    Pipeline Intermediates
    Matured Intermediates
    Pipeline API’s
    Dosage Development
    Pipeline & Matured Intermediates
  • 11. Global Pharmaceutical Outsourcing Opportunity
    Estimated Potential Market:
    Drug Substance
    Formulated Drug
    (in $ bn)
    Current share of outsourcing in defined Contract R&D/Manufacturing space is around ~$35 bn
    Source: Dow Report, AD Little, Cardinal Health
  • 12. Changing Face of Industry
    • Declining R&D output & high costs continue to pose challenges to profitability
    • 13. Blockbuster drug launches expected to drop from 14 in ’03 to 4 in ’08
    • 14. Drug Product Withdrawls (Vioxx) and safety concerns (Crestor)
    • 15. By ’08 patent expirations will account for $ 72 bn in current sales
    Leading to
    Global Outsourcing
    Increase Productivity
    Speed up New product
    D. Expand skills & capabilities
    Source: AT Kearney Report
  • 16. Changing Face of Industry
    • Declining R&D output & high costs continue to pose challenges to profitability
    • 17. Blockbuster drug launches expected to drop from 14 in ’03 to 4 in ’08
    • 18. Drug Product Withdrawls (Vioxx) and safety concerns (Crestor)
    • 19. By ’08 patent expirations will account for $ 72 bn in current sales
    Leading to
    Global Outsourcing
    Increase Productivity
    Speed up New product
    D. Expand skills & capabilities
    Source: AT Kearney Report
  • 20. Facts & Figures - INDIA
    Highest number of FDA approved plants outside USA
    Largely English speaking workforce
    IT capital of the world
    Democracy of 1 billion
    TRIP compliant
    UK based legal system
    Structured and reasonably transparent financial markets & banking system
    Dependent on oil for energy
    Well entrenched entrepreneurial culture & developed private sector
    Superior education level
    Infra-structure in need of development
    Largest market-share in generic API production
    Export & Western oriented
    Economic growth in terms of GDP just slightly behind China
  • 21. Changed IP Scenario in India
    • Global standards followed on IPM
    • 22. CDAs, MoUs, Non-Use Agreements, etc – routinely implemented
    • 23. Work ethics & “Need-to-know” work practices
    • 24. Employee Contracts & Employee retention mechanisms
    • 25. Legal provisions & remedies available
    Cheap Source of
    Qualified API source
    Efficient Process
    R&D Resource
    India is now being looked at as a reliable source
    across the value chain in pharmaceutical industry
  • 26. India Advantage / Disadvantage
    • Language
    • 27. Chemistry, Engineering, Regulatory & QA experience, Dosage expertise
    • 28. Manufacturing Infrastructure
    • Capability in Niche Segments (Ex. Controlled Substances)
    • 29. Communication
    • 30. Emotional blocks (Ex. Compliance, Generic Challenges etc)
  • Medicinal Chemistry
    CMC Development
    Formulation & Development
    Operational Issues & Focus
  • Causes for negative experiences
    Provider specific issues:
    • Environmental issues; license to operate
    • 45. Asset reliability
    • 46. Quality issues
    • 47. “Yes” means, I will do whatever I can, “No” is culturally impolite
    • 48. Communication Issues
  • Key Elements for Pharma Business
    • Delivery Quality
    • Communication Transparency
    • Trustworthiness
    • 52. Flexibility
    • 53. Customer Delight
    .. Favor India as destination
  • 54. Choosing the Right Partner in India;
    a Selection Model
    • Staff Quality
    Final Partner
  • 67. Discovery
    Changing Paradigm
    Range of Services
    From Clinical quantities to Commercial scale
    Outsourcing services +
    In License the product for
    Indian & Asian Markets
    Indian Companies are
    themselves as partners to
    Innovator companies
  • 68. India’s Conclusion of Strengths…
    Competitive Pricing
    Full cGMP
    …combining the best of both worlds
  • 69.
  • 70.
  • 71.
  • 72.
  • 73.
  • 74. Channel
  • 75.
  • 76. Consulting
  • 77. Growth = More
  • 78.
  • 79. Business Development ConsultingOur consulting activities consist of:- Support in business development- Organizing meetings- Developing the commercial approach for a new product or company- Co-founding new business based on promising new technology
  • 80.
  • 81. Regulatory Services consulting
    • Complete database for dossier requirements
    • 82. Quick dossier compilation
    • 83. Draft pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents
    • 84. Clinical and non-clinical overviews
    • 85. Justification for fixed dose combination
    • 86. Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL)
    • 87. Prepare label and carton contents 
    • 88. Reply to MOH queries
    • 89. Product registration assistance
    • 90. Product development assistance
    • 91. Global Patent Information
    • 92. Literature for patented product
    • 93. Non-infringing process
  • Regulatory Complaiance services
    • CGMP / Quality System Auditing
    • 94. Internal GMP Audit
    • 95. Analytical Laboratory Audit
    • 96. Quality System Design & Management
    • 97. Stability Program Design / Implementation
    • 98. Regulatory Submission Preparation for
    Drug Master File (DMF) in CTD
    Certificate of Suitability (COS) Dossiers in CTD
    • Standard Operating Procedure (SOP) Development
    • 99. Revised Schedule 'M' , WHO - GMP, US-FDA,UK-MHRA , Australia - TGA , PIC/s etc. implementation
  • Regulatory Affairs services
    we offer the following services:
    • Technical Data Package for APIs and Intermediates
    • 100. Drug Master Files for APIs and Intermediates in CTD format or Country specific Requirements
    • 101. COS/CEP Filing
    • 102. Drug Product Dossiers
    • 103. Site Accreditation
    • 104. Site Registration
    • 105. Product Registration
    • 106. Check List for Regulatory Audits
  • Product Registration & Audit
    • CGMP / Quality System Auditing
    • 107. Internal GMP Audit
    • 108. Analytical Laboratory Audit
    • 109. Quality System Design & Management
    • 110. Stability Program Design / Implementation
    • 111. Regulatory Submission Preparation (Product Dossier) for the following :
    • 112. European Union (EU) - EMEA Guidelines
    • 113. Ministry of Health - Cambodia
    • 114. Ministry of Health - Ghana
    • 115. Ministry of Health - Myanmar
    • 116. Ministry of Health - Nigeria
    • 117. Ministry of Health - Slovakia
    • 118. Ministry of Health - Sudan
    • 119. Ministry of Health - Ukraine
    • 120. Ministry of Health - Vietnam       and many more........
    • 121. Standard Operating Procedure (SOP) Development Revised Schedule 'M' , WHO - GMP , PIC/s , TGA etc. Implementation .
  • Product &Process Development
    • Formulation Development
    • 122. Excipient / Ingredient Selection
    • 123. Analytical Methods Development
    • 124. Product Development Report Writing
    • 125. Manufacturing Process Development & Assessment
    • 126. Process Optimization and Validation
    • 127. Manufacturing Scale - Up
    • 128. SOP Development
    • 129. Technical Report Writing
    • 130. All work is done at reasonable cost
  • Technical dossier Prepartaion
    our own databank & sources to compile ,edit and create technical dossier on various new and old Bulk drugs & Drug intermediates.
    Each technical dossier consists of the following details :
    • Drug details : CAS No., ATC Code, Chemical name, Molecular formula, Chemical structure, Nomenclature(s), Licensor, Indication(s), Action , Therapeutic class.
    • 131. Synthesis scheme.
    • 132. Drug characterisation (by UV,FTIR,NMR, DSC etc.)
    • 133. Physico-chemical properties.
    • 134. Analytical methodology.
    • 135. Impurity Profile.
    • 136. Patent abstract details.
  • Quality Assurance services
    • WSite Master File Preparation
    • 137. Validation e offer the following services:
    • 138. Master Plan Preparation
    • 139. Quality Manual Preparation
    • 140. Facility Validation
    • 141. Process Equipment Qualification
    • 142. HVAC/AHU System Validation
    • 143. Water System Validation
    • 144. Blending Validation
    • 145. Micronisation Validation
    • 146. Process Validation
    • 147. Cleaning Validation
    • 148. Standard Operating Procedures
    • 149. Documentation as per GMP regulations
    • 150. GMP Audits
    • 151. Check lists for Regulatory Audits
    • 152. Annual Product Review
    • 153. GMP Training Programmes
    • 154. Preparation of Product Manuals
  • Quality Control services
    We offer following services:
    • Quality Control Department Establishment as per GMP requirement
    • 155. Specification and Analytical Procedure Development
    • 156. Standard Operating Procedures
    • 157. Instrument Logbook as per GMP requirements
    • 158. Instrument Qualification
    • 159. Stability Study Protocols
    • 160. Preparation of Calibration Planner
    • 161. Preparation Stability Study Schedule
    • 162. Documentation as per GMP regulations
    • 163. Test Protocols as per GMP requirements
  • Partnering Search
    Our Partnering Search offers advanced and enhanced partnering support.
    Actively working for you, our service enables you to utilize our knowledge and expertise.
    A fully comprehensive solution designed to complement your existing business developement activities.
    As part of the service:
    Based on your brief, our partnering experts will search for partners on your behalf and provide a fully qualified list of target companies (Prospect List)
    On your instruction they will contact target companies on your behalf to make introduction and coordinate initial contact/conference call etc (Hot List)
  • 164. Company profiles
    Our profiling service maximizes your potential of finding the most suitable partner for your opportunities by targeting our focused global business development and licensing audience.
    Pharma licensing Service provides potential partners from all around the world. Whether you are looking to in- or out-license, your profile allows interested parties to contact you directly with solutions that match your needs.
    post detailed information about company and its business development strategy,In- or out-licensing opportunities, or services, Fully categorised listings by sector, therapeutic target and disease
  • 165. Partner Identification
    comprehensive consultancy services to support your partnering activities.
    Our unique service provides you with all of the elements of the licensing process whilst also enabling you to minimize the time and costs associated with it.
    Fitting around your timescale and needs, we work with you as you move through the individual elements of licensing at your own pace.This flexible approach ensures you remain in control as you progress from initial groundwork, through partner identification, to negotiating and closing the deal.
  • 166. Partner Introduction
    Our partner introduction service helps you to progress from a list of companies into active discussions. Following initial review we will, where necessary, work with you to write or improve your non-confidential dossier. This then forms the basis of our initial approach and presentation to potential partners. Building on these initial approaches we arrange meetings for you to take negotiations further.
    We work predominantly on a success fee basis; however the initial upfront fee will vary depending on the status of your non-confidential dossier at initial approach. It is vital that we represent you with the best possible offering to potential partners and will work closely with you to ensure this.
  • 167. Partnership for
    Due Diligence Execution
    with Panel team partnership We are proud to offer comprehensive Service for Due Diligence Execution.
    For the first online research company and has access to a global network of professionals experienced in assessing Intellectual Property ,product, Process & Facility acquisition for clients including top tier pharmaceutical and biotechnology companies.
  • 168. Representation & Deal Closure
    We provide you with a named industry expert who is on hand to support and guide you at any time as you move forward with your deal negotiations. Offering you as much or as little assistance as you require, we bring experience of many successful deals to the table to guide your negotiations as they move through to closure.
    All work is to pre-agreed contractual terms, which are heavily biased towards success payments.
  • 169. Thank You
    Vikram Sathish.A
    Director -Marketing &Sales
    Tri Inpharmex Services Pvt.Ltd