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Member Managers

PharmaDev Partners, LLC operates under confidentiality agreements with its clients. Previous clients include Large Pharmaceutical companies, Virtual companies, Contract Service Organizations, Start Up Pharmaceutical companies, and Technology companies.

• New Product Development (NDA, ANDA, IND, CTX) - API’s, classical drug products, Biologicals, Biotechnology products
  • Steriles (Sterile Fill, Lyophiles)
  • Orals (Tablets/Capsules)
  • Semi-solids (Ointments, Creams)
  • Liquids (Syrups, Elixirs, Suspensions)
  • Inhalation
• Analytical, Pharmaceutical, Chemical Development
• Line Extensions (OTC and Steriles)
• Regulatory Submissions/Dossiers (specifically CMC), US and World
• Computer System Validations (IQ, OQ, PQ)
• Quality Systems Development (Master Documents through implementation)
• 21 CFR Part 11 Assessments
• cGMP Audits
• Record and Batch Reviews
• New Facility Start-ups, Sterile and Non-sterile, Chemical
  • IQ, OQ’s for utilities, water, cold rooms, CIP, COP, HVAC, PLCs, Environmental
• Technical Transfers/Contract Manufacturing
• Strategic Regulatory and Scientific planning from Pre-IND to Post-Approval
• Regulatory and Technical Documentation preparation, review, and critique
• Dossier review and critique
• Project Management of all types of projects listed above
• General Management consulting including strategic planning, staffing and organizational restructuring
• Account Management
• Bid Proposals and Contract Negotiations
• Training (Regulatory, Project Management, Validation, cGMP, Behavioral)

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