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Regulatory Services

Catalyst offers services in both Regulatory Affairs and Quality Assurance

Regulatory Affairs

New regulatory guidelines are continually introduced. To avoid delays and rejections, we have built a regulatory affairs team that provides comprehensive regulatory services to enable you to take your product from IND to NDA or BLA. Unlike other CROs who take an adversarial position with the FDA, our approach considers the FDA to be your partner in development, and together we work to assist our sponsors down the path to approval.

Quality Assurance

Quality assurance starts by having your finger on the pulse of the data and document management process. Catalyst set out from the start to automate data and document management processes by implementing a complementary suite of industry-leading technology including:

  • DocCompliance® 1.3 EDM, a CFR Part 11 compliant electronic document management systems
  • SAS®
  • OmniComm Systems TrialMaster® Internet-based electronic data capture (EDC)
  • Catalyst proprietary Internet-driven project management tools.

By changing manual, paper-driven processes to electronic computer system routines, we save time and money while raising the bar on quality assurance.

Quality is personnel driven, and our QA group periodically reviews all departments to confirm that they are in compliance with the standards of GCP in accordance with Catalyst corporatewide SOPs. Catalyst's highly qualified staff can provide GLP and GMP vendor inspections and investigator protocol/GCP audits for our sponsors to ensure compliance with FDA and ICH guidelines.

In addition, through seamless integration with our sister company, Adept LTD, we can provide regulatory experts fully conversant with the changing European regulatory environment for EU/UK deployed clinical development programs.