A clear path to regulatory approval
Safis Solutions enables life science companies, both large and small, to navigate the regulations by providing clear direction. We will assess your regulatory needs, develop product approval pathways, support clinical studies, and interface with health authorities to achieve regulatory approval. Safis will demonstrate full life-cycle process knowledge at strategic and tactical levels to meet your approval objectives.
Safis recognizes the importance of timely product approvals. Product delays effect everything from your bottom line to improved patient outcomes. Safis works with your staff to expedite the produce approval process.
How we do it
Our staff members provide expert insight and clarity to the regulatory approval process. We successfully assist our clients with global regulatory needs. As a U.S. based company, Safis can serve in the role of an authorized representative for foreign companies. Safis has extensive expertise with FDA, European, Asian, Canadian and several other regulatory health authorities. We provide high-quality submission preparation to accelerate the approval process in these highly-regulated areas:
- Pharmaceutical product approval
- Medical device product approval
- Biologics approval
- Orphan product approval
- Food and cosmetic product approval
- Veterinary product approval
- Support for marketed products
- Post-marketing label evolutions
- Manufacturing strategy changes
- International market approval
- Diagnostic product approval