Drug Development and Strategy

Our experienced staff are dedicated to providing the best quality and service to meet your needs. We can help you in the optimal strategy and development of your product by considering your company’s and product’s specific needs. Typical services include:

  • Regulatory advice on strategy and development
  • Due diligence
  • Paediatric Investigation Plan (PIP)
    • advice on regulation requirements, strategy and development
    • writing (full plans, deferrals, waivers)
    • submission, and follow-up (modifications, annual reports on waiver requests)
  • Orphan Drug Designation
    • advice on regulation requirements
    • writing, submission and follow-up
  • Scientific Advice (EMA, National Agencies): writing of briefing package, submission and follow-up
  • Arranging and/or accompanying clients to meetings with EMA and National Agencies
  • Clinical trials (IMPD, CTA, EC applications, substantial amendments)
  • SME applications to EMA

Interested in our service? Let's talk