Comprehensive Reporting and Medical Writing Services

Our team of medical writers have an average of 25 years experience in the industry working with a broad range of indications and therapeutic areas. We focus on offering flexible solutions to meet your needs at all phases of product development.  We can assist you in the development, preparation, review and publishing of documents in support of regulatory submissions and clinical trials. Our medical writing services include:

  • Study protocols
  • Informed Consent Documents
  • Clinical Study Reports (CSRs)
  • Study Reference Manuals
  • Clinical Trial Registry Documents
  • Safety Narratives
  • Clinical Evaluation Reports (CERs)
  • Investigator’s Brochures (IBs)
  • Investigational New Drug (IND) Applications
  • IND Annual Reports
  • New Drug Applications (NDAs)
  • Drug Master Files (DMFs)
  • eCTDs: Module 2 (2.2, 2.4, 2.5, 2.6, 2.7) and Module 5 (ISS, ISE)
  • 505(b)(2) Searches and Summaries
  • Marketing Applications
  • Orphan Drug Applications
  • Drug Establishment Registration
  • Standard Operating Procedures (SOPs)
  • Meeting Reports
  • Manuscripts for Publication