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Excellence in Regulatory Consulting and Medical Writing Services Since 1987

Medical and Regulatory Writing Services

Hubbell Consulting provides a complete approach to medical and regulatory writing and can assist your company in the development, preparation, and review of documents in support of regulatory submissions and clinical trials, including:

  • Clinical Study Reports (CSRs)
  • Clinical protocols
  • Informed Consent Documents
  • Case Report Forms (CRFs)
  • CRF Manuals
  • Study Reference Manuals
  • Patient Diaries
  • 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
All documents undergo an internal Senior Review to ensure consistency and quality. Documents containing original data undergo a 100% quality control review against source documents.

Medical and Regulatory Writing Workshops and Lectures

Hubbell Consulting presents employee training workshops in regulatory writing. Good Clinical Practices and ICH guidelines are emphasized.

  • Clinical protocol writing workshops
  • Clinical study report writing workshops
  • 505(b)(2) Strategy and submission lectures
  • Good Clinical Practices lectures