Clinical Trial Support Services

Our extensive regulatory intelligence combined with our operational expertise ensures that your clinical trial is aligned with the latest regulatory agency developments.

Regulatory Strategy

Audits and Risk Management Services

We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments

QUALITY

We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments

International Registration

We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments

Global compliance 

We assist manufacturers, importers, and distributors of cosmetic products with cosmetic safety assessments

USA Premarket Submission

A 510(k) is premarket submission made to FDA to demonstrate your device is safe and effective for use and substantially equivalent to a legally marketed device.

MDR and IVDR CE Marking Services

In order to sell your medical devices in Europe, they must first be CE Marked. CE Marking is Europe’s version of marketing approval.