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Development Strategy

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)

ILC has more than 10 years in biotech development strategy, in close interaction with pharmaceutical
Regulatory Affairs

° 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)

ILC can provide regulatory expertise from phase I to NDA
Quality Assurance

° 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)

ILC pays attention to detail along each step of the development