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.
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
- Study design consultation
- Clinical development planning
- Scientific advice assistance – preparation for regulatory authority meetings
- Orphan drug applications
- Advanced therapy medicinal product consultation
Get in touch to find out more about regulatory affairs.