Clinical Regulatory Solutions
As global regulatory requirements continue to evolve our regulatory experts will help you navigate regulatory requirements throughout your product’s development lifecycle.
Across your clinical development journey, consider our Clinical Trial Regulatory Services a hub for all.
Regulatory Strategy
- EU Regulatory pathways incl. clinical strategy – EMA, CE-marking and Notified Body interactions
- US Regulatory pathways incl. clinical strategy – FDA
- Clinical Trial Regulation (CTR)
- Medical Device Regulation (MDR)
- In-Vitro Diagnostic Regulation (IVDR)
Clinical Evidence
- Literature studies
- Clinical studies
- Local single-centre to global multi-centre
- Pre- to Post Market phase
- Regulatory Authorities and Ethics Committees/Institutional Review Boards Submissions
- Clinical Study Report (CSR)
- Legal Representation
- Clinical Evaluation Report (CER)
- Readiness for inspections by Regulatory Authorities
Post Market
- Post Market Surveillance (PMS)
- Post Market Clinical Follow-up (PMCF) incl. design, conduct, analysis and reporting
- CER updates
Contact
Talk to a clinical expert
Don’t hesitate to contact us if you have a clinical program or project coming up. We will provide you with more information on our operations model and provide you with a custom-made and budget-effective solution.