Providing expert insight and clarity
Although we are best known for our work in pharmaceutical, biologics, and medical devices, Safis Solutions assists our clients with global regulatory needs in other highly regulated areas.
Our experience includes:
Regulatory Approval is Critical to Your Success
When the success of your product hinges on regulatory approval, don’t leave it to chance. Safis Solutions has experience with product approvals, regulatory strategies, unique device identification, and more. We are an experienced business ally whose track record you can depend on. For example, we have assisted clients with:
- LDTs (Laboratory-developed Tests) validation requirements
- CAP (College of American Pathologists) laboratory accreditation
- CLIA (Clinical Laboratory Improvement Act) certification