The widespread knowledge of IMP management allows us to provide numerous additional services

• Management of documentation in accordance with GMPs
• Preparation and review of the sections of the clinical protocols relating to the preparation of the IMP
• Drafting of IMPDs, complete or simplified
• Preparation of Investigator’s Brochure (IB) relating to the use of the IMP
• Generation of random lists or MED.ID assignment lists
• Preparation of emergency envelopes
• Release of batches of IMPs carried out by QP in accordance with the directives 2001/20 / EC
• QP Statement in relation to imported IMP products and prepared on the basis of Audit at production sites.