Case Studies
Small pharma seeks regulatory approval.
Safis functions as Regulatory Affairs Department.
Safis works with Australian device company to acquire 510(k)
Regulatory Approval
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. Through all of these steps, Safis will demonstrate regulatory strategy, know-how and excellence in tactical execution to meet your approval objectives.
Safis recognizes the importance of timely product approvals. Product dalays impact everything from your bottom line to improved patient outcomes, so expediency is everything.
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 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 our clients with the high quality submission preparation needed to accelerate the approval process preventing delays 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
- Changing manufacturing strategies
- International market approval
- Diagnostic product approval