Our Services

Empower your organization to operate with efficiency and strategic focus with a full line of medical writing and medical writing support services tailored to address your specific needs. From individual project assignments to assembly and management of full medical writing teams, Faison Associates offers the full spectrum of clinical and regulatory document development support.

    • Protocols and informed consent forms

    • Clinical study reports

    • Patient narratives

    • Investigator brochures

    • Investigational medicinal product dossiers (IMPD)

    • Registry postings

    • Briefing packages

    • NDA/MAA/CTD clinical modules

    • Responses to EMA/FDA questions

    • Integrated summaries of safety & efficacy

    • PIP/PSP & waivers

    • Orphan designation applications

    • Nonclinical

    • Chemistry, manufacturing, and controls (CMC)

    • Project Management

    • Technical Editing

    • Quality Control

    • Publishing

    • Strategic regulatory planning for IND, CTA, NDA, MAA, BLA, and global filings

    • Agency meeting planning and briefing document development (e.g., Pre-IND, EOP, Scientific Advice)

    • Submission strategy development, including gap analyses and roadmaps for success

    • Global regulatory pathway analysis and risk assessment

    • Regulatory project management across regions and cross-functional teams

    • Lifecycle submission management, including amendments, variations, and post-approval filings

    • Regulatory intelligence and policy tracking to align with the latest health authority expectations

    • Style Guides

    • Templates

    • SOPs and Work Instructions

    • Medical Writing Toolbox: citation, referencing, editing, and collaboartive authoring tools

  • Need permanent or temporary positions filled? We can help! Contact us to start the conversation.