Scientific and Medical Writing Services
Medical writing turns clinical, non-clinical, and quality data into the documents that regulators, ethics committees, and reviewers actually read. EvySaif writes across the full document lifecycle: the protocol that starts a trial, the clinical study report that closes it, the aggregate safety reports that run alongside it, and the regulatory submission documents that carry it to an authority. Every document is written to the relevant ICH guidance and aligned to your target market, whether that is India, the GCC, the EU, or the US.
The documents we write
Our writing spans four document families, and the same clinician-led team handles all of them. That is what keeps the protocol, the study report, the safety reports, and the dossier summaries telling one consistent story rather than four separate ones.
Clinical trial protocols
Protocols for Phase 1 through Phase 4 studies, written in line with ICH E6 Good Clinical Practice including the updated E6(R3) principles and ICH E8(R1), with informed consent documents and bioavailability and bioequivalence protocols alongside them.
Clinical study reports
ICH E3 compliant CSRs for Phase 1 through Phase 4 trials, plus synopses, abbreviated and synoptic reports, shell CSRs, and patient safety narratives.
Pharmacovigilance and safety reports
Development Safety Update Reports to ICH E2F, Periodic Benefit-Risk Evaluation Reports to ICH E2C(R2), PADERs for the FDA, and Risk Management Plans.
Regulatory submission documents
CTD and eCTD Module 2 summaries, clinical and non-clinical overviews, briefing documents, and responses to authority queries.
One team, one voice: because the same team writes the protocol, the study report, the safety reports, and the dossier summaries, language and interpretation stay consistent across documents. That consistency is what keeps a submission coherent.
What we prepare
Clinical trial protocolsPhase 1 to 4, with synopses and informed consent documents.
Clinical study reportsICH E3 CSRs, synopses, and abbreviated, synoptic, and shell reports.
Aggregate safety reportsDSUR, PSUR and PBRER, PADER, and Risk Management Plans.
Regulatory submission documentsCTD and eCTD Module 2 summaries and overviews.
Patient safety narrativesFor serious adverse events, SUSARs, and deaths.
Briefing and response documentsMeeting briefing documents and answers to authority queries.
How EvySaif helps
We write to the ICH guidance that governs each document, align it to the authority you are filing with, and keep the language consistent from the protocol through to the dossier. Whether you are filing your first application or scaling a pipeline, we plug in at document level or across a full submission.
Why EvySaif
EvySaif is one of the best research and medical writing consultancies in India, and our writing is clinician-led. That means your documents are reviewed by someone who understands the clinical substance, not just the format. We work to current ICH guidance, align each document to your target market, and deliver at consultancy pricing suited to emerging and mid-size sponsors. Portfolio CSR, DSUR, and PBRER documents are available for review.
Frequently asked questions
Clinical trial protocols and informed consent documents, clinical study reports, aggregate safety reports such as DSURs and PBRERs, and regulatory submission documents including CTD and eCTD Module 2 summaries.
ICH E3 for clinical study reports, ICH E6 GCP including E6(R3) and ICH E8(R1) for protocols, and ICH E2F and E2C(R2) for safety reports, alongside the specific expectations of your target authority.
Yes. The ICH guidelines these documents are built on are the shared standard across the EU, the US, and most Middle East and GCC regulators, so the same documents serve those markets. We write for CDSCO, FDA, EMA, and Middle East authorities.
Yes. We author summaries, reports, and overviews directly from your protocols, statistical outputs, study reports, and quality data, keeping language consistent across the dossier.
Have a different question?
Tell us about your product, market, and timeline, and a clinician on our team will reply with specifics rather than a sales script.
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