Regulatory Services

CTD and ACTD dossier preparation

Most authorities expect registration dossiers in a defined structure — the ICH Common Technical Document (CTD) or the ASEAN Common Technical Dossier (ACTD). We compile and review dossiers in the required format and adapt them to each market’s regional requirements, using checklists built for each target authority.

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See deliverables

Formats ICH CTD (M4), eCTD-ready structure, ASEAN ACTD
Typical inputs Development, manufacturing, stability and BE data
You receive Compiled dossier with a completeness checklist

Overview

About CTD & ACTD Dossiers

The CTD is organised in five modules: Module 1 (regional administrative information), Module 2 (summaries, including the quality overall summary), Module 3 (quality), Module 4 (non-clinical study reports) and Module 5 (clinical study reports). The ACTD used in ASEAN member states organises similar content into four parts: administrative data and product information, quality, non-clinical and clinical.

For generic products, Modules 4 and 5 are usually replaced or reduced by bioequivalence data and literature, but requirements vary by authority. We map your existing data to the required structure, identify gaps and compile a file that reviewers can navigate easily.

Use cases

When this service helps

First registration in a new market

Compile a dossier in the authority’s required format.

Converting CTD to ACTD (or back)

Restructure an existing dossier for ASEAN or ICH-format markets.

Multi-country programmes

A core dossier with country-specific regional sections.

Dossier upgrade

Bring legacy files up to current format and content expectations.

Scope

What the service covers

Regulatory pathway confirmation and country-specific checklist
Module 1 / Part I: application forms, certificates, labelling and regional documents
Module 2 summaries, including the quality overall summary
Module 3 / Part II quality documentation for drug substance and product
Bioequivalence or clinical documentation as required by the authority
Cross-checking for consistency between modules, labels and certificates
Formatting, bookmarking and preparation for publishing

Who does what

Globaxa prepares and checks the dossier. The applicant (or its local agent) signs declarations and submits to the authority. Underlying data — stability, validation and bioequivalence studies — are generated by your teams or contract organisations.

What is the difference between CTD and ACTD?

Both organise the same kinds of information. The CTD has five modules and is used by ICH regions and many others; the ACTD has four parts and is used in ASEAN. The ACTD places administrative and product information together in Part I and has its own requirements (ACTR) for quality and stability data.

Is eCTD required?

It depends on the authority and procedure. Some require eCTD, others accept PDF or paper, and eCTD version 4.0 is being phased in by several authorities. We confirm the requirement for each market.

Methodology

How we work

A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.

Confirm requirementsFormat, procedure and regional documents for each market.
Collect and map dataYour technical documents are mapped to the dossier structure.
Identify gapsMissing or inadequate data are flagged early.
Compile and writeSummaries and sections are written and assembled.
Quality checkCompleteness and consistency are checked against the country checklist.

Deliverables

What you receive

Compiled dossier

CTD or ACTD file ready for publishing and submission.

Country checklist

Requirement-by-requirement completeness record.

Gap and risk list

Open items and likely query areas.

Technical basis

Guidelines we work to

ICH M4 (CTD)Organisation of the common technical document, including M4Q, M4S and M4E.
ICH M8 (eCTD)Electronic CTD specification; versions and implementation dates differ by authority.
ASEAN ACTD and ACTRCommon technical dossier and common technical requirements for ASEAN member states.
National guidanceEach authority’s Module 1 / Part I requirements and local data expectations.

What we need from you

Product development report and manufacturing process description
Specifications, analytical methods and validation reports
Stability data (with climatic zone conditions)
Drug substance information (DMF or open part)
Bioequivalence or clinical data, as applicable
GMP and other certificates required by the target market

Please share confidential information only after an NDA is in place — we are happy to sign one first.

Market and jurisdiction considerations

ASEAN: ACTD format, with country-specific Part I requirements. ICH regions and many others: CTD/eCTD. Africa: many authorities use CTD with their own Module 1; regional joint-assessment initiatives and the African Medicines Agency (operating from Kigali) are shaping procedures. Requirements change frequently, so we confirm them for each submission (information current as of October 2026).

FAQs

CTD & ACTD Dossiers: frequently asked questions

Can one dossier be used for several countries?

A core dossier can be reused, but each market usually needs its own regional section, labelling and sometimes additional data. We plan a core-plus-regional approach.

How long does dossier preparation take?

It depends on how complete your data are and the number of markets. Once we have reviewed your documents we provide a realistic schedule.

Do you write bioequivalence study reports?

Study reports are produced by the bioequivalence centre that conducts the study. We summarise and incorporate them into the dossier.

Talk to us about CTD & ACTD Dossiers

Share your product, target market and timeline. We will review your requirement and propose a defined scope.