Pharma – Biotech – OTC


We provide the following services:

  • U.S. Agent
  • Drug Establishment Registration and Drug Listing
  • Advice on product manufacturing and product specification development.
  • Training on U.S. regulatory processes
  • Review and preparation of IND, NDA, BLA, ANDA, NADA, and prior approval supplement (PAS) all with eCTD format

Contact Us to Receive a Quote