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,
- Advertising control (French Visas GP/PM),
- Regulatory Intelligence,
- Review and validation of packaging items,
- Regulatory strategy, etc.