Regulatory Affairs and Medical Writing
Clinical Research Services /
Regulatory Affairs
and Medical Writing

TRI is experienced in the successful design and implementation of regulatory strategies to optimize your product development pathway. By employing highly qualified staff, some of whom were previously at the FDA, we are able to deliver a portfolio of regulatory and medical writing services to address the needs of every clinical research project.

Key Services

  • Regulatory Consulting
    • Design and implementation of regulatory strategies
    • Optimized strategy based on each FDA Center’s expectations
    • Guidance on the latest regulatory issues and requirements
    • FDA negotiations and appeals
  • Advisory Committee and Panel Meeting Support
    • Strategic development of meeting requests
    • Panel Meeting Package, Expert Reports, Sponsor presentations
    • Identification and management of Subject Matter Experts
    • Coordination of Mock Panels, Preparation Workshops, and other Practice Sessions
  • Investigational Product Applications
    • Evaluation of preclinical program to support the application
    • Pre-Investigational New Drug (IND), Pre-Investigational Device Exemption (IDE), and Pre-New Drug Application (NDA) Briefing Packages
    • IND, IDE, NDA, BLA, and PMA, and Correlative Services Worldwide
    • Annual Reports and Development Safety Update Reports (DSURs)
    • Master Files
    • Investigator’s Brochures
    • Literature reviews and summaries
    • Standard Operating Procedures (SOPs)
  • Clinical Development Phase I-IV
    • Protocols
    • Informed Consents and appropriate translations
    • Clinical Study Reports
  • Post-Marketing
    • Abstracts and manuscripts
    • Design and management of REMS (Risk Evaluation and Mitigation Strategies)

TRI currently manages two of the largest National Institutes of Health IND portfolios of oncology and infectious disease agents. We maintain more than 230 INDs with over 850 protocols, and prepare 40 new INDs per year.

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