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Pharma Regulatory & licensing Service
- Indian pharmaceutical companies have increased R&D spending and are targeting international companies for contract research and manufacturing deals. - The global pharmaceutical outsourcing market was worth $57.2 billion in 2007 and is expected to grow to $76 billion by 2010, with contract research and manufacturing services making up $55.48 billion in 2007. - The Indian pharmaceutical outsourcing market was valued at $1.27 billion in 2007 and is projected to reach $3.33 billion by 2010, growing at a CAGR of 37.6%.
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Pharma Regulatory & licensing Service
- 1. Pharma Regulatory &licensing ServiceBusiness.A.Vikram Sathish
- 3. Indian companies haverecently focused a lot on R&D in the pharmaceutical sector. Many companies now spend 8% or more of revenues on research.
- 4. Many pharma companiesare now actively targeting international companies for contract research and manufacturing (CRAM) deals.
- 5. Medicinal chemistry, customsynthesis, and clinical studies are some areas in which Indian firms are pitching and winning new business.
- 6. The global pharmaceuticaloutsourcing 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 outsourcingmarket 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. SCOPEPharmaceutical companies increasinglyoutsource 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. APIsDiscoveryChemistryFormulationsAdvancedIntermediatesProcessR&DOutsourcing Business SpaceRangeof ServicesFrom Clinical quantities to Commercial scale
- 10. Business SpaceDiscovery ChemistryProcessR& DPipeline IntermediatesMatured IntermediatesBIG PHARMAPipeline API’sMatured API’sDosage DevelopmentCommercial Drug ProductDiscovery ChemistryProcess R& DEMERGING PHARMAPipeline IntermediatesMatured IntermediatesPipeline API’sDosage DevelopmentFINE CHEMICALCOMPANIESPipeline & Matured Intermediates
- 11. Global Pharmaceutical OutsourcingOpportunity Estimated Potential Market:Packaging/Assembly Dosage FormProduc-tionDosage FormDevelop-mentDrug SubstanceProduc-tionProcessDevelop-mentClinicalDevelop-ment Pre- clinicalDevelop-mentDiscoveryResearchPharmaceutical R&DDrug SubstanceSupplyFormulated Drug Supply30-35~5060-80(in $ bn)Current share of outsourcing in defined Contract R&D/Manufacturing space is around ~$35 bnSource: Dow Report, AD Little, Cardinal Health
- 12. Changing Face ofIndustry Declining R&D output & high costs continue to pose challenges to profitability
- 13. Blockbuster druglaunches expected to drop from 14 in ’03 to 4 in ’08
- 14. Drug ProductWithdrawls (Vioxx) and safety concerns (Crestor)
- 15. By ’08patent expirations will account for $ 72 bn in current salesLeading toGlobal OutsourcingDRIVERSCostIncrease ProductivitySpeed up New product DevelopmentD. Expand skills & capabilitiesSource: AT Kearney Report
- 16. Changing Face ofIndustryDeclining R&D output & high costs continue to pose challenges to profitability
- 17. Blockbuster drug launchesexpected to drop from 14 in ’03 to 4 in ’08
- 18. Drug Product Withdrawls(Vioxx) and safety concerns (Crestor)
- 19. By ’08 patentexpirations will account for $ 72 bn in current salesLeading toGlobal OutsourcingDRIVERSCostIncrease ProductivitySpeed up New product DevelopmentD. Expand skills & capabilitiesSource: AT Kearney Report
- 20. Facts & Figures- INDIAHighest number of FDA approved plants outside USALargely English speaking workforceIT capital of the worldDemocracy of 1 billionTRIP compliantUK based legal systemStructured and reasonably transparent financial markets & banking systemDependent on oil for energyWell entrenched entrepreneurial culture & developed private sector Superior education levelInfra-structure in need of developmentLargest market-share in generic API productionExport & Western orientedEconomic growth in terms of GDP just slightly behind China
- 21. Changed IP Scenarioin IndiaGlobal standards followed on IPM
- 22. CDAs, MoUs, Non-UseAgreements, etc – routinely implemented
- 23. Work ethics &“Need-to-know” work practices
- 24. Employee Contracts &Employee retention mechanisms
- 25. Legal provisions &remedies availableCheap Source of intermediatesQualified API sourceAnd Efficient ProcessR&D ResourceIndia is now being looked at as a reliable sourceacross the value chain in pharmaceutical industry
- 26. India Advantage /DisadvantageAdvantagesCostFlexibilitySpeed Language
- 27. Chemistry,Engineering, Regulatory & QA experience, Dosage expertise
- 28. ManufacturingInfrastructureDisadvantages Capability in Niche Segments (Ex. Controlled Substances)
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- 30. Emotional blocks(Ex. Compliance, Generic Challenges etc)Medicinal ChemistryCMC DevelopmentFormulation & DevelopmentOperational Issues & FocusTrack record
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- 44. CommunicationCauses for negativeexperiencesProvider specific issues:Environmental issues; license to operate
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- 47. “Yes” means, Iwill do whatever I can, “No” is culturally impolite
- 48. Communication Issues KeyElements for Pharma BusinessPRODUCT INDUSTRYSERVICE INDUSTRYDIFFERENTIATORS Innovation First to Market
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- 51. Geographical ReachDIFFERENTIATORSSpeedDelivery Quality Cost FrequencyCommunication Transparency Quality Trustworthiness
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- 53. Customer Delight..Favor India as destination
- 54. Choosing the RightPartner in India; a Selection ModelQUALIFIERSDIFFERENTIATORSGlobal Interests
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- 60. Capability & Infrastructure
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- 66. Understanding the West Staff QualityFinal Partner
- 67. DiscoveryChemistryFormulationsAdvancedIntermediatesAPIs Process R&D Changing ParadigmRange of ServicesFrom Clinical quantities to Commercial scaleOutsourcing services + In License the product for Indian & Asian Markets Indian Companies are positioning themselves as partners to Innovator companies
- 68. India’s Conclusion ofStrengths…SpeedCompetitive PricingFull cGMP…combining the best of both worlds
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- 79. Business Development ConsultingOurconsulting 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
- 81. Regulatory ServicesconsultingComplete database for dossier requirements
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- 83. Draft pre-formulation, BMR,MFR, process validation, method validation, dissolution and stability studies documents
- 84. Clinical and non-clinicaloverviews
- 85. Justification for fixeddose combination
- 86. Prepare Summary ofproduct (SmPC) and Pack Information Leaflet (PIL)
- 87. Prepare label andcarton contents
- 88. Reply to MOHqueries
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- 92. Literature for patentedproduct
- 93. Non-infringing processRegulatory Complaianceservices CGMP / Quality System Auditing
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- 96. Quality System Design& Management
- 97. Stability Program Design/ Implementation
- 98. Regulatory Submission Preparationfor 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 serviceswe offer the following services:Technical Data Package for APIs and Intermediates
- 100. Drug Master Filesfor APIs and Intermediates in CTD format or Country specific Requirements
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- 106. Check List forRegulatory AuditsProduct Registration & Audit CGMP / Quality System Auditing
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- 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 DevelopmentFormulation Development
- 122. Excipient / IngredientSelection
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- 124. Product Development ReportWriting
- 125. Manufacturing Process Development& Assessment
- 126. Process Optimization andValidation
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- 130. All work isdone at reasonable cost Technical dossier Prepartaionour 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.
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- 132. Drug characterisation (byUV,FTIR,NMR, DSC etc.)
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- 136. Patent abstract details.Quality Assurance servicesWSite Master File Preparation
- 137. Validation e offerthe following services:
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- 149. Documentation as perGMP regulations
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- 151. Check lists forRegulatory Audits
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- 154. Preparation of ProductManuals Quality Control servicesWe offer following services:Quality Control Department Establishment as per GMP requirement
- 155. Specification and AnalyticalProcedure Development
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- 157. Instrument Logbook asper GMP requirements
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- 160. Preparation of CalibrationPlanner
- 161. Preparation Stability StudySchedule
- 162. Documentation as perGMP regulations
- 163. Test Protocols asper GMP requirements Partnering SearchOur 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 profilesOur profilingservice 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 Identificationcomprehensive consultancyservices 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 IntroductionOur partnerintroduction 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 DueDiligence Executionwith 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 & DealClosureWe 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 VikramSathish.ADirector -Marketing &SalesTri Inpharmex Services Pvt.Ltd