Regulatory Services
The comprehensive portfolio of pharmaceutical regulatory services provided by our regulatory experts includes:
- Regulatory submission experience in
- First in Man and Phase I-III Patient studies with complex biological products & radiopharmaceuticals
- Medical Device Clinical Investigations
- Drug-Device combination studies
- Clinical Trial Applications (CTAs) in more than 30 territories
- EU Clinical Trial Regulation & the Clinical Trial Information System (CTIS)
- Voluntary Harmonisation Procedure (VHP) submissions
- Certified translations and back-translation of clinical trial application documentation into multiple languages