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. We pioneered Quality by Design (QbD) for topicals and understand the nuances of the regulatory landscape.

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.

At Tergus, we leverage our knowledge of regulatory requirements and our deep expertise of topical drug markets to maximize your product’s probability of regulatory success and global sales.

Services Include:

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