Regulatory Support

Tergus provides regulatory guidance to clients developing topical drug products. Our staff has extensive therapeutic area expertise and knowledge of global regulatory compliance. In the United State, we provide full IND, NDA or ANDA CMC support.

Our senior staff has specialized understanding of U.S., European and Asian regulatory requirements for topical drugs and work with clients to develop strategies appropriate for their drug’s performance characteristics.

Our Regulatory Services Include:

  • U.S. Regulatory CMC Support
    • IND
    • NDA
    • ANDA
    • 505(b)(2)
  • European Regulatory Support
    • EMA filings
  • Asian Regulatory Support
    • NHFPC filings (China)
    • MHLW filings (Japan)
    • MFDS filings (South Korea)