Comprehensive Regulatory Services


Catalyst Regulatory Services, LLC provides a wide-range of services targeted to the needs of companies at all stages of development. In 2016, we provided support to 52 pharmaceutical and biotechnology companies.  Our goal is to work collaboratively with these companies to develop innovative, customized, strategic programs that help our clients obtain and maintain the regulatory applications necessary to study investigational drugs and biologics, in pursuit of market approval.

Services provided include:

  • Full-service support
    – Strategy
    – Health authority liaison
    – Operations/submissions
  • Ad hoc consulting on a project basis
    – Strategic guidance
    – Regulatory document publishing
  • Staff augmentation to fill resource gaps in existing regulatory groups

Available expertise includes:

  • Regulatory Strategy (US, Canada and Europe)
    – Initial INDs
    – IND maintenance
    – Health authority meetings
    – Comprehensive strategic plan
  • Regulatory Operations
    – Preparation and submission of regulatory documents for INDs, CTAs, CTAs, NDAs, MAAs