We have a track record of success in navigating the drug development regulatory landscape. Our services include:

Study Design and Oversight

  • Toxicology
  • Create and Review SOPs
  • Pharmacology
  • Clinical Trials (I-IV)

Regulatory Filings

  • Investigational New Drug Application (IND)
  • 505(b)(1) New Drug Application (NDA), 505(b)(2) NDA, 505(j) Abbreviated New Drug Application (ANDA)
  • Combination Products
  • Drug Master Files
  • Compliance Planning and Strategy
  • Manuscript and Report Writing
  • Scientific and Regulatory Due Diligence Assessments