Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Medical Writing Services India | CDSCO Sugam · eCTD · ICH E6(R3)

Auriga Research delivers medical writing and regulatory submission services for pharmaceutical, biotechnology, nutraceutical, and consumer health companies. Our medical writers prepare clinical study reports, Investigator Brochures, eCTD CTD modules, manuscripts, and submission packages that meet CDSCO, FDA, and EMA requirements.

All deliverables follow ICH E6(R3) (effective May 2025, superseding E6 R2), ICH E3 for CSRs, and ICH M4 for CTD/eCTD formatting. Regulatory documents are submission-ready for the CDSCO Sugam portal — including clinical trial applications, SAE reports, and investigator mapping. eCTD format is mandatory for CDSCO new drug submissions since 2019.

Medical writing can be engaged independently — a single CSR, an IB, a CTD Module, or a peer-reviewed manuscript — without committing to full trial management. It is also delivered as part of Auriga's full-service CRO offering, where the medical writing team works inside the same integrated platform as biostatistics, clinical operations, and pharmacovigilance.

Request a Proposal Call +91-7428116100

Why Auriga Research for Medical Writing

Medical writing quality directly impacts regulatory review timelines. Incomplete or poorly structured submissions lead to deficiency letters, delays, and increased costs. Auriga's integrated CRO + analytical-lab model under one management means writers have direct access to source data, statistical output, and PV signals.

ICH E6(R3)

Current GCP guideline · effective May 2025

eCTD

Mandatory for CDSCO new drug submissions since 2019

Sugam

CDSCO portal submission-ready · SAE · investigator mapping

Standalone

Engage a single document — no full CRO commitment required

Medical Writing Deliverables

From protocol development through final regulatory submission and peer-reviewed publication — every document your clinical programme requires.

Clinical Study Reports (CSR)

Full ICH E3 compliant CSRs including synopsis, study design, statistical methodology, efficacy and safety results, individual patient data listings, and appendices. Submission-ready for CDSCO Sugam, FDA, and EMA.

Study Completion Reports (SCR)

Concise study completion reports for post-marketing surveillance, Real World Studies, and investigator-initiated studies — formatted for CDSCO closeout and journal annexes.

Manuscript & Publication Support

Peer-reviewed journal manuscripts, conference abstracts, posters, and submission/revision cycle support per ICMJE recommendations and GPP3. Available independent of trial management.

Investigator Brochures (IB)

IB documents compiling preclinical data, clinical pharmacology, prior clinical experience, adverse event profiles, and dosing rationale. Updated per ICH E6(R3) requirements through the study lifecycle.

eCTD Modules — CDSCO / FDA / EMA

Module 1 (administrative), Module 2 summaries, and Module 5 clinical reports formatted per ICH M4 and the receiving authority's eCTD specification. Mandatory for CDSCO new drug submissions since 2019.

Regulatory Submissions — Sugam Ready

Complete CDSCO submission packages (Form CT-04, CT-06), FDA IND / NDA / ANDA filings, and EMA MAA. CDSCO documents are Sugam portal submission-ready including investigator mapping and SAE reporting templates.

Protocols & Amendments

Study protocols with objectives, endpoints, statistical analysis plans, inclusion/exclusion criteria, and visit schedules. Protocol amendments include detailed rationale and regulatory notification packages per ICH E6(R3) risk-based quality management.

Informed Consent Forms (ICF)

Ethics Committee-ready ICFs in English and regional languages, incorporating ICMR National Ethical Guidelines, Schedule Y, and ICH E6(R3) informed consent elements (including electronic ICF support).

PSUR / PBRER / DSUR

Periodic Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Development Safety Update Reports per ICH E2C(R2) and CDSCO requirements — produced alongside our Pharmacovigilance division.

Regulatory Pathways We Support

CDSCO (India) — Sugam Portal

  • ✓ New drug clinical trial permissions (Form CT-04 / CT-06) via Sugam
  • ✓ Import and manufacturing licence applications
  • ✓ SEC dossier preparation and investigator mapping
  • ✓ Expedited SAE / SUSAR reporting via Sugam
  • ✓ Post-marketing surveillance and PSUR submissions
  • ✓ eCTD format mandatory since 2019 for new drug applications

FDA / EMA / Global

  • ✓ FDA IND, NDA, ANDA submissions and annual reports
  • ✓ EMA Marketing Authorisation Application (MAA)
  • ✓ eCTD publishing per FDA / EMA specifications
  • ✓ Health Canada CTA and NDS submissions
  • ✓ MHRA, TGA, and other ICH M4 member jurisdictions
  • ✓ Regulatory query responses and deficiency-letter resolution

Related CRO Services

Phase II–IV Trials CDSCO CRO · 370 investigator sites Biostatistics & Data ICH E9(R1) · CDISC · SAS + R Pharmacovigilance PSUR · PBRER · Signal detection Site Management 370 investigator sites · 100+ SMOs BA/BE Monitoring & PK Independent monitoring · Phoenix WinNonLin Pharmaceutical Testing Analytical, stability, microbiology

Frequently Asked Questions

Can Auriga handle medical writing without managing the full trial?
Yes. Medical writing at Auriga can be engaged independently — from protocol development and Investigator Brochure writing at study start, through CSR and manuscript preparation at study close — or as part of our full-service CRO offering. Sponsors can scope a single document (e.g., a CSR or a single CTD module) without committing to broader trial management.
Is Auriga compliant with ICH E6(R3) GCP?
Yes. All medical-writing deliverables align with ICH E6(R3) — the current Good Clinical Practice guideline, effective May 2025 and superseding E6(R2). Protocols, Investigator Brochures, Informed Consent Forms, and study monitoring documentation reflect the E6(R3) risk-based quality management and electronic-records expectations.
Does Auriga prepare CDSCO submissions on the Sugam portal?
Yes. Regulatory documents prepared at Auriga are submission-ready for the CDSCO Sugam portal — clinical trial applications (Form CT-04 / CT-06), expedited SAE and SUSAR reporting, investigator mapping, and Subject Expert Committee dossiers. Our medical writing team is experienced in Sugam-format document preparation and the procedural quirks of the portal.
Does Auriga prepare documents in eCTD format?
Yes. Documents are prepared in eCTD (Electronic Common Technical Document) format for CDSCO new drug submissions (mandatory since 2019), FDA IND / NDA / ANDA filings, and EMA Marketing Authorisation Applications. Module 1 (administrative), Module 2 (summaries), Module 3 (quality), Module 4 (non-clinical), and Module 5 (clinical) are formatted per ICH M4 and the receiving authority's specifications.
What is the typical timeline for a clinical study report (CSR)?
A CSR prepared per ICH E3 typically takes 8-12 weeks from database lock to final approved report, depending on study complexity, endpoint count, and statistical analyses. BA/BE monitoring engagement CSRs may complete in 4-6 weeks. Phase III pivotal trial CSRs with multiple efficacy and safety analyses may require 12-16 weeks. Milestone-based timelines and review cycles are agreed at the project-scoping stage.
How is the CTD structured for CDSCO new drug submissions?
CDSCO CTD submissions follow the ICH M4 structure with India-specific Module 1: cover letter, application forms (CT-04 / CT-06), authorisation letters, GMP certificates, and Form 30. Module 2 carries the Quality Overall Summary, Non-clinical Overview, and Clinical Overview/Summary. Module 3 holds CMC (drug substance, drug product, stability). Module 4 holds non-clinical study reports. Module 5 holds clinical study reports and tabulated patient data. Submission is via the Sugam portal in eCTD format.
Does Auriga write manuscripts for peer-reviewed publication?
Yes. Auriga's medical writing team prepares peer-reviewed journal manuscripts and supports submission and revision cycles — primary publications, sub-group analyses, secondary endpoint analyses, post-hoc reports, conference abstracts, and posters. We follow ICMJE recommendations, GPP3 (Good Publication Practice), and journal-specific submission requirements. Manuscript writing can be scoped independently of trial management.
What does ICH E6(R3) change for protocols and Investigator Brochures?
ICH E6(R3) reframes GCP around risk-based quality management, sponsor oversight, and electronic records. Protocols now require explicit risk assessment and quality-tolerance limits; Investigator Brochures emphasise integrated benefit-risk and updated safety data; ICFs accommodate electronic informed consent. Auriga updates all template inventory and SOPs to the E6(R3) requirements so deliverables reflect current expectations of FDA, EMA, MHRA, Health Canada, and CDSCO.

Start Your Medical Writing Project

ICH E6(R3) compliant · eCTD CTD modules · CDSCO Sugam submission · CSR, IB, and manuscript writing. Scoped independently or as part of full CRO engagement. Proposal within 5 business days.

+91-7428116100 Request a Proposal

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