Regulatory Affairs

We have regulatory experts based in over 50 countries. Each one knows their territory inside out and can brief you on country-specific regulatory and ethics requirements, as well advising on legal and scientific restraints from a global perspective.

In-depth knowledge

Expertise in therapeutic indication means we can provide expert advice for clinical development in specific areas and orphan indications.

Regulatory services we provide include:

Clinical Trial Regulatory Support

  • Submission requirement consultation
  • Preparation and management of clinical trial applications to regulatory authorities
  • Substantial amendments
  • End of trial and study outcome reporting

Regulatory Consultancy

  • Study design consultation
  • Clinical development planning
  • Scientific advice assistance – preparation for regulatory authority meetings
  • Orphan drug applications
  • Advanced therapy medicinal product consultation

Find out more about how we have invested in the best in class E-Clinical Technologies and our Project Management Office to provide you with leading quality services.

Get in touch to find out more about regulatory affairs.

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