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Regulatory, clinical, and scientific writing

turns complex data into rigorous, compliant documents.

At Geistek, our Medical Writing service bridges science and regulation. We partner with you to translate your study data into format-ready, authority-grade documents that support approvals, publications, and market access.

What We Do

We deliver a full suite of writing services across all phases of development, product types, and regulatory environments.

Protocols & Investigator’s Brochures (IB)

Clinical Study Reports (CSR) and Clinical Study Summaries

Summary of Product Characteristics (SmPC), labelling, package inserts

Module writing for CTD / eCTD submissions

Clinical Evaluation Reports (CER) & Post-Market Clinical Follow-up (PMCF)

Manuscripts, posters, abstracts, and scientific publications

Safety narratives and integrated summaries

Dossier sections: nonclinical, PK/PD, clinical overview

Our Approach & Quality Standards

Quality, compliance, and clarity at the foundation of every document.

Protocols & Investigator’s Brochures (IB)

All content is rooted in rigorous data interpretation and scientific justification.

Regulatory alignment

Every document adheres to relevant guidelines (ICH, GCP, EMA, FDA) and tailored agency style.

Modular writing

Flexible, reusable content modules that streamline cross-document consistency.

Quality control

Multi-level peer review, consistency checks, language/grammar, style compliance.

Formatting & eSubmission readiness

Documents are prepared in agency-compliant formats (Word, PDF, eCTD module specs).

Editorial transparency

Full version control, reference linking, tracked changes, and audit trails.

Let’s Work Together

If you’re looking to ensure scientific documents are submission-ready, publication-grade, and compliant across jurisdictions, let us help bring clarity, precision, and regulatory alignment to your writing.

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