Regulatory Affairs

Our Regulatory Services

  1. Regulatory Strategy

    We analyze each project in a personalized way in order to provide each client the regulatory support needed. Sound strategy is essential for pharmaceutical product development and successful dossier registration.

  2. CEPs and ASMFs Preparation

    Services for active ingredient manufacturers preparing registration dossiers for EdQM (CEP) and finished product manufacturers (ASMF), including deficiency resolution and product lifecycle maintenance.

  3. Finished Product Dossier Documentation

    Support for various dossier types including innovative, generic, bibliographic, and medicinal plants for human and veterinary medicines, including readability tests and regulatory requirements.

  4. Authorization Requests

    Centralized Procedures (PC), Decentralized Procedures (PDC) and Mutual Recognition (PRM), FDA projects (IND, NDA, BLA, ANDA).

  5. Post-Authorization Maintenance

    Variation management (types IA, IAIN, IB, II), e-CTD submissions, ownership transfers, suspensions, revocations, and promotional material review.

  6. Audits and Dossier Compiling

    Documentation support for dossier purchases/sales and legacy document updates to ensure compliance.

  7. Legislative Review

    Keeping clients updated on regulatory changes affecting medicines and ensuring ongoing compliance with evolving legislation.

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