CTD and eCTD dossiers, authored in Mumbai, filed in your market.
Every registration we supply into starts as a Common Technical Document. M Care's in-house regulatory affairs team writes the dossier alongside the Indian manufacturer — Module 3 CMC, the Module 2 summaries, the regional Module 1 — and hands the marketing-authorisation holder a submission-ready pack.
ICH M4. Five modules. One harmonised registration file.
The Common Technical Document was adopted by ICH in 2000 and is the format every major regulator now accepts for a new marketing-authorisation application. M Care authors the technical modules; the overseas marketing-authorisation holder files them under their own licence.
The five-module structure
Module 1 is the regional administrative pack and varies by country. Module 2 carries the CTD summaries — the Quality Overall Summary (M4Q), Non-clinical Overview (M4S) and Clinical Overview (M4E). Module 3 is the Quality / CMC core. Modules 4 and 5 hold the non-clinical and clinical study reports. M Care writes the technical pack; you file the registration.
CTD or eCTD, by market
eCTD (ICH M8) is mandatory for the EMA, MHRA, Health Canada, PMDA, Swissmedic, the GCC Centralised Procedure since the 2020 mandate, WHO-PQ and an expanding list of African regulators. Paper-plus-PDF CTD remains in use in several Africa and SEA markets. We prepare whichever lifecycle the file sits in, using the same technical content.
Author side, not holder side
M Care is the dossier-authoring partner to the Indian manufacturer. The marketing-authorisation holder in your market — the importer, the local agent, the MoH registrant — owns the submission. We produce the file; you sign the application form. The arrangement mirrors how CDSCO, BfArM and the SFDA expect the dossier chain to be documented.
Why an overseas registrant picks up the phone.
Fresh MA application, generic product
A GCC importer pursuing a Centralised SFDA / MOHAP registration. A Nigerian agent filing at NAFDAC for a generic already licensed elsewhere. The registrant has the local Module 1 pack under control; the Module 3 CMC, Module 2 QOS and bioequivalence data live with the Indian manufacturer, and that's where the dossier has to be written.
Variation or renewal due
A Type IA, IA(IN), IB or Type II variation after a specification change, an added manufacturing site, a shelf-life extension or a five-year renewal. The manufacturer amends Module 3; we rebuild the affected sections, prepare the variation form references and supply the revised dossier into the holder's eCTD sequence.
Switch of manufacturer or site
An overseas holder moving from an ex-originator to an Indian WHO-GMP source, or switching between two Indian sites within the same group. M Care compiles the bridging Module 3 — comparative specifications, method transfer, stability bracketing — in a format the receiving regulator will accept without a fresh clinical application.
WHO-PQ and tender-grade filings
Global Fund, Stop TB and UNICEF tenders frequently require a WHO Prequalification dossier or a recognised SRA approval as entry criteria. We prepare the WHO-PQ-format dossier from the same Module 3 source, with the Product Information Documents and site summary the WHO-PQ team expects.
Module by module. Specification by specification.
Every file is compiled against ICH Q-series guidelines and the relevant regional Module 1 template. Cross-references resolve. Hyperlinks work. Granularity matches the receiving regulator's validation rules.
Module 1 — regional pack
The administrative layer, built to the regulator's current template: EU M1 v3.0.4, UK M1 post-Brexit, GCC M1, the ACTD Part I for Philippines MAA, or the NAFDAC / SAHPRA / PPB national formats. Application form, cover letters, labelling, SmPC or equivalent, proof of registration in the country of origin.
Module 2 — CTD summaries
Quality Overall Summary (M4Q) mirroring Module 3 at the 30-50 page level. Non-clinical Overview and written summary (M4S) for the API class. Clinical Overview and summary (M4E) pulling across the bioequivalence and literature data. Authored by the regulatory team, QC-read by the manufacturer.
Module 3 — Quality / CMC
3.2.S for the drug substance — synthesis, characterisation, control of materials, impurities, specifications, stability. 3.2.P for the finished product — formulation, development, manufacture, control, reference standards, container closure, stability. 3.2.A appendices and 3.2.R regional information completed per market.
CEP or open-part DMF
Where the API site holds an EDQM Certificate of Suitability, the CEP is filed in 3.2.S in place of the full substance section. Otherwise the API maker supplies an open-part DMF to the registrant and the closed part direct to the regulator. We coordinate both paths, and cite the reference numbers the regulator expects.
Bioequivalence and clinical
For generic filings the pivotal BE study sits under 5.3.1.2 with the protocol, clinical study report, bioanalytical validation and statistical analysis. Literature-based Module 4 non-clinical summaries are compiled against the published evidence where a new non-clinical programme is not required.
Stability — ICH Q1A(R2), Zone IVb
GCC and tropical-market dossiers carry 30°C / 75% RH long-term data (Zone IVb), minimum 12 months at submission, with 6-month accelerated at 40°C / 75% RH. Temperate-zone dossiers run to 25°C / 60% RH. Stability commitments and ongoing protocols written into Module 3 per ICH Q1.
Scoping to submission. With RTQ cover.
- Scope and regulatory strategy. Molecule, dosage form, target markets, timing. We map the regional Module 1 variants, confirm whether CEP or DMF is viable, flag where bioequivalence data already exists and quote a realistic drafting window.
- Gap analysis on source data. The manufacturer's existing tech-transfer dossier, stability file, validation reports and BE study are audited against the target regulator's expectations. Gaps are listed with owners — extra stability point, method re-validation, impurity qualification — before authoring starts.
- Module 3 authoring. 3.2.S and 3.2.P are written by the regulatory team in the manufacturer's plant, with the QA head and analytical development as named reviewers. Specifications, methods and validation reports pulled directly from the manufacturing licence file, not paraphrased.
- Module 1 and the CTD summaries. Regional Module 1 assembled to the regulator's current template. QOS, Non-clinical Overview and Clinical Overview drafted and cross-referenced to Modules 3, 4 and 5. For eCTD markets, the sequence is built, validated against regional DTD and hyperlink-checked.
- Submission support and RTQ handling. The pack is delivered to the overseas marketing-authorisation holder for filing. Regulator questions (RTQs, deficiency letters, Day-120 lists) are triaged with the manufacturer, responses drafted, and the variation sequence loaded when the file moves into life-cycle.
Dossier preparation — the specifics.
Can you author both CTD and eCTD, or only one?
Both. The technical content — Module 3 CMC, Module 2 summaries, Module 4 and 5 reports — is format-agnostic. What changes is the assembly: eCTD markets (EMA, MHRA, Health Canada, PMDA, Swissmedic, GCC Centralised, WHO-PQ and a growing list of African regulators) need the XML backbone, DTD-validated sequence and hyperlinked granularity; paper-plus-PDF markets take the same content in a tabbed volume set. We deliver whichever the receiving regulator mandates.
Are you the marketing-authorisation holder?
No. M Care is the dossier-authoring partner to the Indian manufacturer. The marketing-authorisation holder in your market — the importer, the local agent, the MoH registrant — files the application under their own licence and carries the post-authorisation obligations. This is the standard arrangement CDSCO, the SFDA, MOHAP and NAFDAC expect to see documented in the dossier chain.
How long does a generic CTD dossier take to author?
A new generic Module 3 with bioequivalence data already in hand is typically 10-14 weeks from kick-off to submission-ready pack. Add 4-8 weeks if a BE study needs commissioning. Add 6 months if long-term stability is not yet at the minimum ICH Q1A(R2) 12-month mark required for registration. Variations and renewals are faster — commonly 3-6 weeks.
Which regional Module 1 templates do you prepare?
EU Module 1 v3.0.4 and UK Module 1 post-Brexit for EMA / MHRA filings. GCC Module 1 for the Saudi SFDA, UAE MOHAP, Kuwait, Oman, Qatar, Bahrain and Jordan submissions. NAFDAC, SAHPRA, PPB Kenya and the ASEAN Common Technical Dossier Part I for Philippines MAA. WHO-PQ format for prequalification dossiers. Where a market uses its own template, we build to that.
Do you handle the API section via DMF or CEP?
Either route. Where the API manufacturer holds an EDQM Certificate of Suitability to the European Pharmacopoeia, the CEP is filed in 3.2.S and the full substance section is not required. Otherwise the API maker supplies the open part of a Drug Master File to the registrant for the dossier, and the closed part direct to the regulator. Both paths are coordinated and the reference numbers cited correctly.
What stability data do you include for GCC markets?
GCC sits in Climatic Zone IVb. Long-term stability runs at 30°C / 75% RH with a minimum 12 months of data at submission; accelerated at 40°C / 75% RH for 6 months minimum. Stability is written against ICH Q1A(R2), with ongoing commitments and the stability protocol specified in Module 3.2.P.8. Temperate-zone dossiers run at 25°C / 60% RH long-term.
What happens after submission if the regulator asks questions?
Regulator questions — EMA Day-120 lists, MHRA RFI, SFDA deficiency letters, NAFDAC queries — are triaged with the Indian manufacturer within 48 hours of receipt. Technical responses are drafted, the relevant Module 3 sections revised if needed, and the amended sequence loaded for the holder to file. RTQ cover runs through to marketing authorisation.
Can the dossier be reused across multiple markets?
The Module 3 CMC and the Module 2 summaries travel almost unchanged between ICH-aligned regulators. Module 1 is rebuilt per market. Labelling, SmPC or product information, and regional variations in stability zone or specification sometimes trigger small Module 3 adjustments. A dossier written for EU CTD typically seeds a GCC Centralised file and a WHO-PQ file with 10-20% incremental work.
Molecule, target markets, current dossier status. That's the conversation.
Tell us what you're registering, where, and what data already exists. We'll come back with a realistic drafting window, a gap list and a quote inside two working days.