Life Science

Regulatory affairs

In the healthcare industry, regulatory control is essential to guarantee access and distribution of products to global markets.

Our regulatory expertise supports you in the stages of approval, compliance, data and risk management, product modification and post-marketing surveillance.


  • Regulatory strategy for health products
  • Drafting of submission files in CTD / eCTD formats (Modules 1 to 5) in national, centralized (CP), decentralized (DCP) or mutual recognition (MRP) procedures
  • File submission, registration follow-up, answers to questions from health authorities
  • Regulatory maintenance (update of module 3, variations, renewals, transfer, DMI, operating establishment opening file)


Medical devices :

  • Analysis of the normative and regulatory context of your projects in development
  • Creation of technical design files, FDA, Health Canada and European submissions
  • Renewals and market retention