Drug Development Strategy

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  • Drug Development Strategy
  • Product development of orphan drugs, Pharmaceutical, Biotech, NBE, ATMPs, vaccines, generics, biosimilars, plasma-derived products and cosmetics.
  • Regulatory advice in early development up to life-cycle management for all kind of products, and by developing innovative and successful registration strategies to minimize registration timing.
  • Preparation and submission of Marketing Authorisation Applications, Variations, Renewals…
  • Management of Centralised Procedure (Europe & GCC-DR), DCP, MRP and national procedures.
  • In-Vitro Diagnostics (IVD) medical devices registration and distribution in Europe and Middle East.

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