Regulatory Affairs

Quality regulatory submissions maximize research investments, accelerate the time to market and bring the benefit of new treatments to patients faster. From early-phase development through life-cycle management, we use a standardized library of document templates, publishing tools, and processes to produce compliant regulatory submission documentation, reports and dossiers. The Translational Medicine Group believes in planning for compliance and providing the highest standard of regulatory support services for our clients.

Our planning expertise includes strategic regulatory advice, scientific and safety consulting, and product development plans, for pharmaceuticals, biologics, and devices in major therapeutic areas. We provide guidance regarding designation, prepare Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and identify key studies and supporting information required for filing. We will partner with you to determine the most efficient regulatory pathway for your new therapeutic.

We assemble an experienced team to prepare, coordinate, and facilitate regulatory submissions. Our regulatory team provides ICH compliant medical writing, document review, publishing services, submission maintenance activities, and document quality control. We have extensive experience with clinical and nonclinical protocols, clinical study reports, investigator brochures, INDs, IDEs, CTAs, Biologics License Applications (BLAs), andNew Drug Applications (NDAs) in electronic or paper formats.

We provide regulatory agency meeting support with the FDA, EMEA and other national regulatory agencies. Our regulatory agency interactions include initiating contact with the agency, meeting planning, preparation and presentation, advisory meeting support, scientific advice, direct interactions with regulators, pre-meeting briefing packages, and post-meeting issue analysis and response.

Our regulatory team also assists with the preparation, review and submission of all documents required by Partners Healthcare IRB (Insight/eIRB). We review Protocols, Investigator Brochures and Informed Consent Forms for potential problems prior to submission to prevent delays in the approval process. In partnership with the Partners Human Research Committee, we provide access to prioritized reviewing procedures. Our team manages the entire submission process including responses to review, continuing review and closeout. We also provide assistance with registration requirements.

  • Global Regulatory Experience
    • FDA
    • EMA
    • PMDA
    • Health Canada
  • Documentation and Submission CTD/eCTD
    • Request for Designation
    • Briefing Packages
    • pre-IND
    • NDA
    • ANDA
    • Dossiers
  • Meetings
    • Type A
    • Type B: pre-IND, end-of-phase 2, pre-phase 3, and pre-NDA/biologics license application
    • Type C
    • Advisory Committee