Research & Development
Consulting

For your innovative projects, Atessia brings you its pharmaceutical, non-clinical and clinical expertise.

  • Galenic and analytical development
  • Search for GLP subcontractors for non-clinical studies
  • Search for subcontractors for clinical studies
  • Bibliographical research
  • Organizing meetings with the authorities
  • Drafting the briefing packages
  • Assistance with the authorities
  • Assistance with writing test protocols
  • Filing strategy (“Voluntary Harmonization Procedure”)
  • Drafting and compiling clinical trial application files (IMPD, IND, investigator’s brochure)
  • Regulatory submission to authorities and ethics committees
  • Approving packaging items
  • Regulatory contact point for the follow-up of clinical trials
  • Strategy for initiating a cohort ATU (ATUc) or early access: eligibility, positioning, reverse planning
  • Drafting Therapeutic Use Protocols (PUT)
  • Submitting the early access request to the French authorities
  • Support for ATU-MA transitions with post-ATU device management
  • Operating the ATU via our specialist operational partners

Assistance with developing your Paediatric Investigation Plan (PIP)

Orphan Drug Designation (ODD) applications

Further information

Download the document "Innovation from clinical trials to compassionate use"
Download the document "L'enregistrement des médicaments humains et vétérinaires"

“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.