OUR EXPERTISE
Our expertise covers French, European and international markets, ensuring full compliance and optimum management of your regulatory files.
- Preparation of marketing authorization applications and management of the marketing authorization lifecycle
We take charge of the complete preparation of your Marketing Authorization (MA) applications, ensuring their submission and the follow-up of their registration procedures. We also handle the preparation of your dossiers throughout the lifecycle of your marketing authorization applications. Whether for national, European, or international applications, we guarantee a presentation that complies with current regulatory requirements.
- Publishing
Our publishing service includes the compilation, formatting, and electronic submission of your regulatory files.
- Control of Promotional Items and Validation of Packaging Items
Our teams will ensure that promotional elements and/or packaging items comply with current regulations and guidelines. They will also check that claims made in promotional materials are truthful and supported by scientific evidence or validated data.
- Regulatory Watch
We continuously monitor regulatory changes so that you can anticipate and react quickly to changes impacting your business.
- Shortage Management Plan
We develop and implement your shortage management plans to help you anticipate and manage out-of-stock situations.
- Procedures to the ANSM
We support you in all your dealings with the French National Agency for the Safety of Medicines and Health Products (ANSM). Whether it’s for import authorization applications, export declarations, marketing declarations, AMM expiry, or annual declarations of the state of establishment, we ensure efficient preparation and rigorous follow-up of your files.
- LEA and Transparency in Health
We can help you manage your declaration of interest and transparency obligations. Our team ensures that your declarations comply with the requirements of the Transparency of Benefits Act (TBA) and other applicable regulations.
For more information on our regulatory services and discussion of your specific requirements, please contact us. We are here to support you and guarantee a quality service that meets the requirements of the authorities as well as your needs and expectations.
