A well-designed development plan, in accordance with state of the Art, scientific data and relevant guidelines, is a necessary prerequisite to obtain a marketing authorisation.
WHITE-TILLET assists you for:
- the preparation of development plans for:
- Quality (API synthesis, galenic development),
- Nonclinical (PD, PK, toxicology),
- and clinical;
- And more specifically in clinical:
- Validation of clinical trial protocols;
- Follow-up of studies and trials;
- Analysis of study or trial results.
Tillet Y and Lebrun A. What you Need to Know about the New Regulations for Biomedical Research in France. Thérapie Nov-Dec 2006;61(6):463-466.
24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France