clinCORE’s SMEs will provide comprehensive Regulatory affairs support to clients during all stages of the drug development process. We are well-versed in all aspects of the clinical trial submission process, to both IRBs/ethics committees and FDA. Highly qualified medical writers, regulatory staff, data managers, and statisticians work with your team to ensure the clinical, scientific, and regulatory success of every project – from pre-IND/IND/IMPD submission through marketing application submission and regulatory review.

Our SMEs are focused on producing the most meaningful, comprehensive, and submission-ready compilation of your non-clinical and clinical data and manufacturing information – ensuring compliance with FDA and other regulatory agency requirements and guaranteeing every phase of trial is correctly focused for optimum results.

Services include

  • Strategic guidance on the clinical development plan of a new product, including new chemical entity and 505(b)(2) applications.
  • Development and submission of pre-IND and pre-NDA Briefing Packages.
    • Formulation of pre-IND and pre-NDA questions to the FDA.
    • Authoring and compilation of briefing package materials.
    • Correspondence with the FDA on pre- and post-meeting logistics, action items, etc.
    • Participation in FDA meetings.
  • Preparation of the Initial IND.
    • Author Clinical Components (e.g., Introductory Statement, Investigators Brochure, and Protocols)
    • Compilation of additional submission components.
    • Ensure consistency in presentation across all component of the IND.
  • Preparation and coordination of responses to FDA Requests for Information.
  • IND Amendments.
    • Project management and strategic guidance for the life of the IND.
    • Compilation and submission of Protocols, CMC Updates, Nonclinical Study Reports, and Clinical Study Reports.
  • Preparation and submission of 7-Day and 15-Day Safety Reports.
  • Preparation and submission of Annual Reports.
  • Preparation and submission of NDA and sNDA as eCTD.

Investigational New Drug (IND)

The Regulatory Affairs Department compiles all components of your Investigational New Drug (IND) applications, including nonclinical and clinical summaries, investigator brochures and updates. Leveraging our insight into the specific areas of drug approval and our successful track record of communication with the FDA, we expedite your original IND submission to accelerate the drug development process. Our highly qualified medical writers and regulatory staff apply the principles of good scientific and medical writing when preparing your IND documents, facilitating approval of applications to conduct clinical trials of new drugs.

Our IND associated goals and responsibilities include

  • Pre-IND and Pre-NDA meetings (briefing book preparation, meeting support and attendance, and regulatory strategy guidance).
  • IND submission and maintenance (protocol submissions as IND Amendments).
  • NDA submission supports.
  • IND maintenance (submission and tracking of IND Safety Reports, Annual Reports, and Amendments).