• Regulatory affairs


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.





  • 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 & 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).



  • Renewals.
  • Evaluation & updates in compliance with regulations in force.