Regulatory and Document Management

Regulatory Affairs

Clinipace Worldwide offers you a team of Global Regulatory Affairs professionals who have vast experience working with FDA (USA), TPD (Canada), EMEA (European Union), GTA (Australia and NZ) and similar agencies around the world. This team has expertise in both pre and post-marketing drug safety regulations, document management, regulatory filings, global marketing authorization applications, variations and renewals and carefully developed due diligence strategies.

Regulatory Document Management

Clinipace Worldwide prepares all major regulatory submissions and provides extensive quality control review for all trial related documentation, such as:

  • Regulatory Agency and IRB/EC submissions
  • Procurement of Import/Export license, as applicable
  • Initial submissions, amendments, notifications, and closeout submissions
  • Clinical trial agreements and contracts (site, investigator, laboratory, etc.)

Working as a collaborative team, our regulatory document specialists coordinate all aspects of your trial's document collection and submissions, including:

  • Manage all regulatory documentation as part of the start-up, conduct, and close-out phases
  • Coordinates Informed Consent Forms (ICF) processes to ensure study sites meet local requirements
  • Coordinates all document translations
  • Coordinates clinical trial application filings to domestic and international regulatory agencies
  • Ensures submissions comply with applicable local regulations
  • Manages submissions and document storage processes
  • Stays abreast of all regulations to ensure documentation compliance