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:
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Clinical Study Reports (CSRs)
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Clinical protocols
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Informed Consent Documents
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Case Report Forms
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Study Reference Manuals
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Patient Diaries
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Clinical Trial Registry documents
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Safety Narratives
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Investigator's Brochures (IBs)
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Investigational New Drug (IND) Applications
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IND Annual Reports
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New Drug Applications (NDAs)
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Abbreviated New Drug Applications (ANDAs)
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Drug Master Files (DMFs)
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eCTDs (CSE, CSS, ISE, ISS)
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505(b)(2) Searches and Summaries
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Marketing Applications
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Orphan Drug Applications
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Drug Establishment Registration
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Standard Operating Procedures (SOPs)
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Meeting reports
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Manuscripts for publication
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Clinical Evaluation Reports (CERs)
All documents undergo a 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
Hubbell Consulting presents employee training workshops in regulatory writing. Good Clinical Practices and ICH guidelines are emphasized.
