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