Biologics

Helping get your product to market faster

 

Biologics, while similar to pharmaceuticals in some ways, have unique regulatory requirements. When you need a clear pathway to regulatory approval, turn to Safis Solutions.

 

We can assess your needs, develop product approval pathways, support clinical studies, and interface with health authorities to achieve regulatory approval.

 

  biologics vial

 

Developing Product Approval Pathways

 

Our staff members provide expert insight and clarity to the regulatory approval process. Safis Solutions can determine which regulatory requirements apply to you and provide high-quality submission preparation to accelerate the approval process. We have experience with biologics-specific requirements, including:

 

  • BLA (Biologics License Application)
  • IND submissions (Investigational New Drug Application)
  • NDA submissions (New Drug Application)