Bureau de travail

REGULATORY AFFAIRS

Meeting your current need

  • Medical devices :

- Regulatory strategy : definition and optimization of access to markets targeted by your company's marketing strategy,

- CE marking : construction / verification of CE marking files and in particular the technical documentation of your products in relation to the new MD regulations,

- Export : support for regulatory registration of your products outside the EU : USA, Canada, Australia, Brazil, China, Japan, etc.

- Other activities : Gap Analysis of MDD / MDR Technical Files for the new CE marking, definition of GSPRs, list of applicable norms and standards, RA contact towards notified bodies, TF updates following design modifications, etc. .

 

  • Medicinal products :

- Preparation and international registrations in connection with your local partners,

- Marketing authorisation renewals,

- Variations,

- Advertising control (French Visas GP/PM),

- Regulatory Intelligence,

- Review and validation of packaging items,

- Regulatory strategy, etc.