Expert in product registration and regulatory affairs for product licensing


Ictyopharma benefits from regulatory expertise to ensure a high level technical and scientific support for product registration in Aquatic animal health. With over 30 years of experience in product development and registration, Ictyopharma’s experts offer:

  • Audit/technical and regulatory evaluation of pharmaceutical dossiers
  • Evaluation of technical data (particular focus on biologicals)
  • Regulatory strategy proposal
  • Writing of part II (quality documentation) and part IC (Quality: tables and expert reports)
    • Original applications
    • Variations
    • Updating/renewal
    • Answers to questions of Agencies
  • Writing of part III – safety
    • Documentation: publications, specific studies
    • Synthesis of documentation, tabular summaries
    • Expert reports
  • Writing of part IV – Efficacy
    • Documentation: publications, specific studies
    • Synthesis of documentation, tabular summaries
    • Expert reports

A complete support

  • A full support on all aspects of product registration worldwide.
  • Special expertise in obtaining Marketing Authorizations for Biologicals (vaccines).
  • Support for all aspects of a registration dossier i.e. Manufacturing and Quality (CMC part), the Safety file and the Efficacy file.
  • Expertise in new products registration and support for existing products (variations and/or line extensions).
  • Full knowledge on Regulatory processes i.e. Central, De-central, Mutual Recognition and National procedures.
  • The entire regulatory procedure can be taken care of (Dossier compilation, Q&A, and the coordination of the whole regulatory process).



Our assets

Our expert collaborators have a proven track record in all aspects of pharmaceutical, biological and nutritional product development, genetic breeding and regulatory affairs.

We are

Specialized - Independent - Reliable