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Regulatory affairs
OUR EXPERTISE
A network of experts is available to support your projects from development to commercialization of your drug product & throughout all the life-cycle management. Moreover, for each project a regulatory expert is dedicated as a direct contact.
Our field team is located on production / development sites, in close collaboration with operational experts. The regulatory monitoring, advice & expertise are led in an international environment.
Services
IND / IMPD
- Redaction of Quality sections of IMPD / IND.
Industrial projects
- Strategy, redaction, submission & follow-up (e.g.: transfer of products, addition of analytical methods, change of packaging…).
CTD Dossier
- Redaction of Administrative sections: module 1.
- Redaction of Quality sections: modules 2 & 3 (MAA, NDA, ANDA).
Variations
- Variations & grouping of variations (types IA, IB & II).
- Answers to questions from Health Authorities.
Registration Procedures
- Centralized, decentralized, national & mutual recognition procedures.
- International registrations in cooperation with subsidiaries.
- Support for scientific advices.
- eCTD submissions / publishing (via CESP, EMA Gateway).
Maintenance
- Renewals.
- Evaluation & updates in compliance with regulations in force.