FDA Regulatory And Compliance

Regulatory Affairs

The laws and regulations that govern pharmaceutical and medical product industry are both vast and complicated.

Vastek has the expertise and provides services in the following areas.

– Investigation New Drug Application (IND)

– New Drug Application (NDA)

– Common Technical Document Summary

– 510 (K) Premarket Notification (Traditional, Abbreviated, Special, De Novo

– PreMarket Approval (PMA)