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Regulatory Affairs

With 40 years of regulatory experience throughout the product lifecycle for drugs, devices, OTC, and medical foods, we are immensely qualified to drive the regulatory framework for successful and more rapid approval. We work with you to reduce risk, increase compliance, and improve efficiency.

Our regulatory experts are ready to support your:

  • Pre-IND/CTA implementation

  • IND/CTA submission & routine management

  • Types A, B, C, EOP2 submissions & meetings

  • ANDS/SNDA submission

  • OTC, Rx → OTC switch

  • SPA strategy and submission

  • Pre-NDA/BLA submission

  • Peri/Post approval

  • 505(b)(2) strategy development and implementation

  • GLP Program

  • GMP Program

  • Labelling and Risk Management


  • Annual Reporting (DSUR, PSUR)

  • Orphan Drug Designation/Annual Reporting

  • Global Publishing and eCTD Submissions

  • ICSR/aggregate PV Reporting

Contact us today for regulatory affairs guidance.

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