REGULATORY AND MEDICAL WRITING

Our regulatory and clinical team has extensive knowledge in the regulatory, industry and scientific areas required for the preparation of documents. We have years of experience writing regulatory and clinical documents for submission to regulatory authorities. We are able to present the information to the regulatory authorities in a clear and concise document. We deliver a quality document in the expected timeline.

  • Pre-IND Briefing Documents

  • INDs

  • White Papers

  • Annual Reports (INDs, NDAs, DSURs, etc)

  • FDA Meeting Requests and all types of briefing documents

  • Orphan Drug Applications

  • Rare Disease Applications

  • Fast Track and Breakthrough Designation Applications

  • Accelerated Approval Requests

  • NDA, BLA, NADA

REGULATORY DOCUMENTS

We are experienced in writing and editing the following types of documents:

MEDICAL WRITING

Our regulatory and clinical team members are experts in medical writing . They are knowledgeable in the specific language, formats and requirements needed for these documents to ensure regulatory compliance.

  • Investigator Brochures

  • Safety Narratives

  • Protocols

  • CSRs

  • SOPs

Contact us today to learn how we can assist you with Regulatory and Medical writing.