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Regulatory Medical Writing & Consulting Services | Fatemeh Hadi, PhD

A modern, quiet conference room designed for biotech and pharmaceutical consulting meetings, entirely empty of people. At the center is a long, matte white table with three open folders labeled “Biotech,” “Pharma,” and “Medical Devices,” each containing neatly arranged printed charts and structured text. A large wall-mounted screen at the far end displays an out-of-focus regulatory submission timeline in muted blues and greys. Floor-to-ceiling windows on one side allow soft, overcast daylight to fill the room, creating gentle reflections on the table’s surface. Minimalist chairs with dark fabric line the table, slightly out of focus. Photographic realism captured from a slightly low, wide-angle perspective emphasizes clarity, organization, and strategic planning in a calm, professional atmosphere.

Regulatory Writing

Expert medical writing and consulting to accelerate high-quality clinical and regulatory submissions worldwide.

Services

A meticulously organized medical writing workspace without any people, featuring an open silver laptop displaying a clean, text-based regulatory document layout on a large, matte-finish monitor beside it. The desk is a smooth light-wood surface with a slim black keyboard, a fountain pen resting on a printed protocol draft, and neatly stacked binders labeled “Protocols,” “CSRs,” and “Regulatory Strategy.” In the background, softly blurred shelves hold scientific reference books and a discreet model of a double helix. Soft daylight from an unseen window to the left creates gentle highlights on the laptop edges and casts calm, directional shadows. Photographic realism, captured at eye level with a shallow depth of field, conveys a professional, focused, and trustworthy atmosphere suitable for a regulatory medical writing consultancy homepage.

End-to-end development of protocols, CSRs, IBs, and clinical summaries aligned with ICH, EMA, and FDA expectations.

A close-up, photographic realistic still life of regulatory documents spread across a sleek dark-grey desk, with no people present. A detailed clinical study protocol, safety narrative, and CSR synopsis are visible, their headings and structured sections clear but non-legible. A matte black pen rests diagonally across the top document, next to a pair of understated, rimless glasses folded neatly. A tablet device lies off to the side, showing a blurred dashboard of timelines and milestones. Cool, diffused overhead lighting softly illuminates the paper textures and creates subtle reflections on the tablet screen. Shot from a slightly elevated angle with balanced composition, the scene feels precise, methodical, and highly professional, emphasizing accuracy and structure in regulatory medical writing.

Regulatory strategy support, gap analyses, and response drafting to strengthen interactions with ethics committees and health authorities.

List of Services

Regulatory Medical Writing

Providing high-quality, regulatory-compliant documents to support clinical development programs and regulatory submissions.

Services Include:

  • Clinical Study Protocols
  • Clinical Study Reports (CSRs)
  • Investigator’s Brochures (IBs)
  • Informed Consent Forms (ICFs)
  • Regulatory Briefing Documents
  • IND/CTA Submission Documents
  • NDA/BLA Submission Support
  • Common Technical Document (CTD) Summaries
  • Safety Narratives
  • Risk Management Documentation
  • Clinical Development Plans
  • Regulatory Response Documents
  • Medical Device Clinical Evaluation Reports (CERs)

Clinical & Scientific Writing

Supporting the communication of scientific and clinical evidence for research, development, and publication.

Services Include:

  • Literature Reviews
  • Systematic Literature Reviews
  • Scientific Reports
  • White Papers
  • Scientific Summaries
  • Medical Education Materials
  • Slide Deck Content Development
  • Scientific Content Review and Editing
  • Medical Communications

Manuscript Development & Publication Consulting

Helping researchers, clinicians, and organizations prepare manuscripts for peer-reviewed publication.

Services Include:

  • Manuscript Writing
  • Manuscript Editing and Revision
  • Journal Selection Support
  • Publication Strategy Consulting
  • Abstract Development
  • Conference Poster Content
  • Conference Presentation Content
  • Response-to-Reviewer Letters
  • Publication Readiness Assessment

Grant Writing & Funding Support

Assisting investigators and organizations in developing competitive funding applications.

Services Include:

  • Grant Proposal Writing
  • Specific Aims Development
  • Research Proposal Development
  • Scientific Editing of Grant Applications
  • Funding Opportunity Analysis
  • Grant Application Review
  • Project Summaries and Lay Summaries
  • Budget Narrative Support
  • Resubmission Strategy Support

Medical Device Documentation

Supporting clinical and regulatory documentation for medical devices.

Services Include:

  • Clinical Evaluation Reports (CERs)
  • Clinical Evaluation Summaries
  • Literature Review for Medical Devices
  • Post-Market Clinical Follow-Up (PMCF) Documentation
  • Benefit-Risk Assessments
  • Technical Documentation Support

Consulting & Quality Review

Providing expert review and strategic support to ensure document quality and regulatory readiness.

Services Include:

  • Quality Control (QC) Review
  • Medical Editing
  • Scientific Editing
  • Document Compliance Review
  • Gap Analysis
  • Regulatory Documentation Consulting
  • Publication Consulting
  • AI-Assisted Medical Writing Consultation

Pricing

Project Based

  • Projects are typically priced as fixed-fee packages, scoped to your protocol, indication, and timelines. For ongoing or multi-asset support, I also offer retainer-based engagements with a defined number of hours per month for regulatory writing, strategic input, and document QC.

✓ Protocol drafting

✓ CSR development

✓ IB updates

✓ Submission support

Strategic Retainer

  • To support clear budgeting, estimates are provided upfront for each deliverable, including assumptions about complexity, number of rounds of review, and regulatory deadlines. For long-term partnerships, volume-based discounts and phased invoicing can be arranged to align with your development milestones.

✓ Annual planning

✓ Portfolio oversight

✓ Cross-functional liaison

✓ Advisory support

Submit Brief

Share your study details, timelines, and budget to receive a tailored proposal for regulatory writing and consulting support.

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