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