Services

Regulatory and Scientific Advice

 

Our experienced team members, specifically our experts in clinical pharmacology, are capable of preparing a drug development concept for every stage of your product.

CCDRD supports its clients in Scientific Advice procedures with all European Regulatory Authorities, EMA and FDA. On behalf of and in cooperation with the sponsor, we are capable of providing the appropriate clinical development concept and questions to the CHMP or the FDA with the aim of achieving marketing authorization with the minimal number of trials.

Services offered:

  • Creating a drug development program
  • Performing scientific advice with target authority
  • Regulatory advice with regards to CHMP and FDA guidelines
  • Feasibility evaluation
  • Evaluation of pharmacokinetic data based on an inhouse database and scientific resources
  • Validated sample size evaluation