Regulatory medical writing built for the submission, not the file drawer
Regulatory medical writing services across the CTD and eCTD from a clinician led team serving India, MENA, Europe, and global markets.
Regulatory medical writing is the discipline of turning clinical and non-clinical data into the documents a health authority needs to make a decision. It is distinct from scientific or promotional writing in one decisive way: the audience is an assessor working through a structured dossier, and the document has to answer the questions that assessor will ask, in the format and sequence the Common Technical Document (CTD) prescribes.
EvySaif provides regulatory medical writing across the full CTD and its electronic form, the eCTD: Module 2 summaries, Module 5 clinical documents, and the supporting narratives and briefing packages that carry a program through review. Every document is written by a clinician led team to ICH standards, with the source data verified and the regulatory logic made explicit rather than assumed. The same team handles the regulatory submissions the writing supports, so the document and the strategy behind it stay aligned.
The CTD documents we write
- Module 2 summaries: the Clinical Overview (2.5), Clinical Summary (2.7), and Non-clinical Overview and Summaries (2.4, 2.6), which are the documents assessors read first and weight most heavily.
- Clinical study reports: full CSRs to ICH E3, abbreviated reports, and integrated summaries of safety and efficacy, connected to our dedicated clinical study report writing.
- Protocols and investigator brochures: clinical trial protocols, protocol amendments, and IBs, linked to our protocol writing services.
- Briefing and response documents: pre-submission briefing packages, scientific advice requests, and structured responses to health authority questions.
eCTD, structure, and traceability
The eCTD is not merely the electronic wrapper of the CTD; its granularity, hyperlinking, and lifecycle sequencing shape how a document is written. We write with the eCTD structure in mind, so cross-references resolve, hyperlinks target the right granular unit, and each document occupies its correct place in the submission hierarchy. The result is a dossier that an assessor can navigate, which is a quiet but real determinant of review speed.
What we deliver
CTD Module 2 summaries
Clinical Overview and Clinical Summary written to interpret the data for assessors, not merely restate it, with the benefit-risk argument made explicitly.
Clinical and non-clinical documents
CSRs, integrated summaries, and non-clinical overviews to ICH E3 and related guidelines, verified against source outputs.
Briefing and advice packages
Scientific advice and pre-submission briefing documents that frame the right questions for the authority meeting.
Query responses
Structured, clinically reasoned responses to assessment questions from the US FDA, EMA, CDSCO, and other authorities.
Built to the standards that matter
Frequently asked questions
What is the difference between the CTD and the eCTD?
The CTD is the harmonized content and format for a marketing application, organized in five modules. The eCTD is its electronic specification, adding granularity, hyperlinking, and lifecycle management. We write content to the CTD structure and prepare it for eCTD assembly.
Which regulatory documents do you write most often?
Module 2 clinical summaries and overviews, clinical study reports, and health authority query responses are our highest volume regulatory documents, followed by protocols and briefing packages.
Do you write for multiple regulatory markets?
Yes. The CTD is harmonized across ICH regions, and we adapt the market specific elements for the US FDA, EMA, CDSCO, and other authorities from a consistent core, which is far more efficient than writing each market from scratch.