ICH E3 Compliant · CTD Format

Medical Writing & Regulatory Submissions India | CRO Services

Auriga Research provides medical writing and regulatory submission services for pharmaceutical, biotechnology, cosmetic, and nutraceutical companies. Our medical writers prepare clinical study reports, investigator brochures, CTD modules, regulatory dossiers, and submission packages that meet CDSCO, FDA, and EMA requirements.

Every document is authored by writers with postgraduate qualifications in pharmacology, clinical research, or life sciences, and reviewed by our regulatory affairs team. We follow ICH E3 guidelines for clinical study reports, ICH M4 for CTD formatting, and ICH E6 R2 for GCP-related documentation.

As part of Auriga Research's integrated CRO division, our medical writing team works alongside biostatisticians, clinical operations, and pharmacovigilance specialists. This means faster document turnaround, fewer queries during review cycles, and regulatory submissions that are complete on first filing.

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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.

ICH E3

Clinical study reports prepared per ICH E3 structure and content guidelines

eCTD

Electronic Common Technical Document formatting for FDA, EMA, and CDSCO submissions

Integrated CRO

Direct access to biostatistics, clinical data, and pharmacovigilance teams under one roof

Medical Writing Deliverables

From protocol development through final regulatory submission — every document your clinical programme requires.

Clinical Study Reports

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

Investigator Brochures

Comprehensive IB documents compiling preclinical data, clinical pharmacology, prior clinical experience, adverse event profiles, and dosing rationale. Updated per ICH E6 R2 requirements throughout the study lifecycle.

CTD Modules

Module 2 summaries (quality overall summary, clinical overview, non-clinical overview) and Module 5 clinical study reports formatted per ICH M4 guidelines for global regulatory submissions.

Regulatory Submissions

Complete submission packages for CDSCO (Form CT-04, CT-06), FDA (IND, NDA, ANDA, eCTD), and EMA (MAA) pathways. Includes cover letters, application forms, and all supporting documentation.

Protocols & Amendments

Study protocols with objectives, endpoints, statistical analysis plans, inclusion/exclusion criteria, and visit schedules. Protocol amendments with detailed rationale and regulatory notification packages.

Informed Consent Forms

Ethics Committee-ready ICFs in English and regional languages, incorporating ICMR National Ethical Guidelines, Schedule Y requirements, and ICH-GCP E6 R2 informed consent elements.

Regulatory Pathways We Support

CDSCO (India)

✓ New drug clinical trial permissions (Form CT-04)
✓ Import and manufacturing licence applications
✓ Post-marketing surveillance reports
✓ Periodic safety update reports (PSURs)

FDA / EMA (International)

✓ IND applications and annual reports
✓ NDA and ANDA submission packages
✓ MAA (Marketing Authorisation Application) for EMA
✓ eCTD publishing and submission

Related CRO Services

Clinical Trials Phase I-III, bioanalytical, HRIPT Biostatistics SAPs, CDISC, data management Pharmacovigilance Safety monitoring, PSURs, signal detection Site Management Investigator selection, monitoring Pharmaceutical Testing Analytical, stability, microbiology CDMO Services Contract manufacturing & formulation

Frequently Asked Questions

What is the typical timeline for a clinical study report (CSR)?

A clinical study report prepared per ICH E3 guidelines typically takes 8-12 weeks from database lock to final approved report, depending on study complexity, number of endpoints, and statistical analyses required. Bioequivalence study CSRs may be completed in 4-6 weeks, while Phase III pivotal trial CSRs with multiple efficacy and safety analyses may require 12-16 weeks. Auriga Research provides milestone-based timelines during the project scoping phase.

What regulatory submission formats does Auriga Research support?

Auriga Research prepares regulatory documents in CTD (Common Technical Document) format for CDSCO, FDA (eCTD), and EMA submissions. We compile Module 1 (administrative), Module 2 (summaries including quality overall summary, clinical overview, clinical summary), Module 3 (quality/CMC), Module 4 (non-clinical), and Module 5 (clinical study reports and tabulations). Our team also prepares ANDA submissions, IND applications, and post-marketing periodic safety update reports.

Do you prepare documents for CDSCO new drug applications?

Yes. Our medical writing team has direct experience with CDSCO submission requirements under the New Drugs and Clinical Trials Rules, 2019. We prepare Form CT-04 applications, clinical trial protocols, investigator brochures, informed consent forms, and complete CTD dossiers for new drug approvals, clinical trial permissions, and import/manufacturing licences. All documents are reviewed by our regulatory affairs specialists before submission.

Start Your Medical Writing Project

ICH E3 clinical study reports, CTD modules, and regulatory submission packages prepared by experienced medical writers. Get a proposal within 5 business days.

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