Research & Development
Consulting
For your innovative projects, Atessia brings you its pharmaceutical, non-clinical and clinical expertise.
Development strategy with the support of recognized pharmaceutical, non-clinical and clinical experts
- Galenic and analytical development
- Search for GLP subcontractors for non-clinical studies
- Search for subcontractors for clinical studies
- Bibliographical research
Request for a scientific opinion from the national and European authorities
- Organizing meetings with the authorities
- Drafting the briefing packages
- Assistance with the authorities
Clinical trial application (CTA) and clinical research files for Europe, the United States and Canada (via our network of partners)
- Writing Assistance via privileged partners (protocol, investigator’s brochure, investigational medicinal product dossier (IMPD))
- Filing strategy (initial application, amendments, CTIS)
- Preparation of CTA and clinical research files – research involving humans – 1 (interventional), 2, 3 (observational), RIPH on medical devices and without health products
- Regulatory submission to authorities and ethics committees
- Regulatory contact point for the follow-up of clinical trials
Early Access & compassionate use in France
- Strategy for initiating an early access (AAP): eligibility, positioning, reverse planning
- Drafting Therapeutic Use Protocols (PUT)
- Submitting the early access request to the French authorities
- Support for AAP-MA transition
- Support to answer to French authorities for compassionate use
- Operating the AAP via our specialist operational partners
Assistance with developing your Paediatric Investigation Plan (PIP)
Orphan Drug Designation (ODD) applications
Further information
“Research Tax Credit” (CIR) approval issued by the Ministry of Research:
By delegating your R&D projects to us, you can be reimbursed for certain project-related expenses.