We guide and collaborate with you

° Pre-clinical, clinical and regulatory strategy

° Detailed evaluation of target indication including unmeet needs

° Market analysis including competition and potential sales in target indication

° Project plan development from preclinical to phase III (Timelines and Budget)

° Regulatory Strategy

° Regulatory writing and management for local competent authorities, EMA and FDA:

• Orphan drug,
• IND,
• Scientific advice,
• SPA,
• NDA

° Expertise in the development of new compounds (non clinical, CMC and clinical area)

° We create, implement, and maintain Standard Operating Procedures (SOPs) for trial execution

° We provide regulatory intelligence and support in French & European Directives, ICH GCP regulation, Pharmacovigilance, epidemiology and biotechnology departments

° We control clinical research process (audits of sites, clinical documents, subcontractors)