Regulatory affairs: complete submission files, right first time
I prepare, submit and follow up authorisation requests for interventional and non-interventional studies and medical device investigations, within the timelines set by EU and French regulations.
What I take care of
- Collection and review of regulatory and essential documents (protocol, investigator’s brochure, information sheets, insurance, CVs, agreements).
- Medicinal product trial applications in CTIS under EU Regulation 536/2014, parts I and II, and follow-up of requests for information (RFIs).
- Ethics committee (CPP) submissions through the French SI RIPH platform for research involving human participants (Jardé law, categories 1, 2 and 3).
- ANSM applications for medical device clinical investigations (EU Regulation 2017/745) and substantial modifications.
- Data protection compliance: CNIL reference methodologies (MR-001, MR-003, MR-004) or CESREES/CNIL authorisation.
- Declarations under French anti-gift and transparency rules for healthcare professionals.
- Experience with submissions outside the EU (Tunisia).
Frequently asked questions
What sponsors, CROs and sites most often ask me before a mission starts.
Can you handle a CTIS submission end to end?
Yes. I prepare part I and part II documents, submit in CTIS on behalf of the sponsor (with the user roles they assign) and follow up requests for information until the decision.
Do you work as a local French regulatory contact for foreign sponsors?
Yes. I regularly help international sponsors and CROs with French-specific requirements: CPP, ANSM, CNIL and hospital agreements.
Need help with this?
Leave your details and a few words about your study: I will get back to you within 2 business days.