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Audits & Gap Assessments

Regulatory and dossier gap analysis

Most dossier deficiencies can be predicted. A regulatory gap analysis compares your existing documentation with what the target authority expects — format, content and data — so you can close gaps before submission instead of answering queries afterwards.

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See deliverables
  • Typical scope CTD/ACTD dossiers, DMFs, technical files, registered details
  • Typical inputs Existing dossier, target market, product type
  • You receive Gap analysis report and remediation plan
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Overview

About Regulatory Gap Analysis

A dossier prepared for one authority rarely fits another without changes. Module 1 is always regional; quality data expectations, stability conditions, bioequivalence requirements and labelling rules also differ. Gaps that are found early are faster and cheaper to fix.

We review the dossier or DMF section by section against the target market’s requirements and recent query trends, and classify each gap by whether it would block submission, likely trigger a query or simply improve the file.

Use cases

When this service helps

Entering a new market

Adapt an existing dossier to a new authority’s format and requirements.

Before re-registration or renewal

Check that the file reflects current requirements and site practices.

After a refusal or many queries

Understand why and fix the file before resubmitting.

Acquired products

Assess the quality of dossiers transferred from another company.

Scope

What the service covers

  • Format and completeness check against the target structure (CTD, ACTD or national format)
  • Module 1 / Part I regional administrative requirements
  • Quality (Module 3 / Part II) data adequacy, including stability zone requirements
  • Non-clinical and clinical summaries, including bioequivalence where required
  • Consistency between dossier, site practice and product labelling
  • Classification of gaps and a remediation plan

Who does what

Globaxa reviews and advises; generating new data (for example stability or bioequivalence studies) is done by your teams or contract organisations.

Why do stability zones matter?

Long-term stability conditions depend on the climatic zone of the market. Many markets in Africa and Asia are Zone IVa or IVb (hot and humid), so data generated only at Zone II conditions may not be sufficient.

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.

  1. Define the targetMarket, procedure and product type are confirmed.
  2. Review the fileSection-by-section comparison with requirements.
  3. Classify gapsBlocking, likely query or improvement.
  4. Plan remediationActions, responsibilities and realistic sequencing.

Deliverables

What you receive

Gap analysis report

Each gap referenced to the dossier section and requirement.

Remediation plan

Prioritised actions to make the file submission-ready.

Technical basis

Guidelines we work to

  • ICH M4 (CTD)Common technical document structure used by ICH regions and many others.
  • ASEAN Common Technical Dossier (ACTD) and ACTRFormat and requirements used by ASEAN member states.
  • ICH Q1A(R2) and WHO stability guidanceStability expectations, including climatic zone conditions for target markets.
  • National regulations and guidanceEach authority’s specific requirements for Module 1 and local data.

What we need from you

  • Existing dossier or DMF (or the relevant modules)
  • Target market(s) and procedure type
  • Previous queries or assessment reports
  • Current specifications, process and labelling

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

Market and jurisdiction considerations

Requirements vary widely: ICH regions use CTD/eCTD; ASEAN uses ACTD; many African authorities use CTD with their own Module 1 and may participate in regional joint assessment procedures. We confirm the current requirements for each market at the start of the work.

Related services

Regulatory Services

CTD & ACTD Dossiers

Dossiers compiled in ICH CTD or ASEAN ACTD format, adapted to each target market’s regional requirements.

Regulatory Services

Deficiency & Query Handling

Structured, evidence-based responses to deficiency letters and authority queries, coordinated across your technical teams.

Audits & Gap Assessments

Gap Assessments

Site and quality-system assessments against WHO GMP, EU GMP, PIC/S, US FDA or Revised Schedule M, with a prioritised remediation plan.

FAQs

Regulatory Gap Analysis: frequently asked questions

How is this different from your Gap Assessments service?

Gap Assessments look at a manufacturing site’s GMP compliance. Regulatory gap analysis looks at the documents you submit to an authority.

Can you review just one module?

Yes. Many clients ask us to review Module 3 or Module 1 only.

Do you know the requirements for every country?

No consultant knows every country in detail. We confirm the current requirements for your target markets from official sources before reviewing the file.

Talk to us about Regulatory Gap Analysis

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

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