Regulatory Services

Regulatory submission support and lifecycle management

A complete dossier still has to reach the authority in the right form, be tracked through review and be maintained after approval. We support the whole submission lifecycle — planning, publishing, tracking, and the variations, renewals and re-registrations that keep products on the market.

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Lifecycle stages New applications, variations, renewals, re-registrations
Typical inputs Approved dossier, change details, registration list
You receive Submission packages and a registration tracker

Overview

About Regulatory Submission Support

Submission requirements cover more than content: file formats, portal procedures, fees, certificates and legalisation, local-agent documents and sample requirements. After approval, every change to the product, process, site or labelling must be assessed for its regulatory impact and filed in the right category in each market.

We help you plan submissions, prepare compliant packages, track applications and maintain a clear view of registrations, renewal dates and pending changes across markets.

Use cases

When this service helps

New product submissions

Prepare and check the package before it goes to the authority or agent.

Post-approval changes

Assess changes and prepare variation filings in each market.

Renewals and re-registrations

Plan and prepare renewals ahead of expiry.

Portfolio oversight

Maintain a single view of registrations and commitments.

Scope

What the service covers

Submission planning and country-specific checklists
Dossier publishing and technical validation (including eCTD where required)
Certificates, legalisation and local-agent documentation
Application tracking and correspondence management
Regulatory impact assessment of changes and variation filings
Renewal and re-registration planning and preparation
Registration database and lifecycle tracker

Who does what

Submissions are made by the applicant, marketing authorisation holder or authorised local agent; Globaxa prepares the packages and coordinates the process. Review timelines are set by each authority.

Why does one change need different filings?

Each authority classifies changes differently. The same site or process change may be a notification in one market and a prior-approval variation in another, so each market is assessed separately.

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.

PlanRequirements, documents and timelines for each submission.
PreparePackages are compiled, published and validated.
TrackApplications are followed through review with you or your agent.
MaintainChanges, renewals and commitments are managed over the product lifecycle.

Deliverables

What you receive

Submission packages

Complete, validated files ready for submission.

Change assessments

Regulatory impact and filing category for each change and market.

Registration tracker

Status, expiry dates and commitments across markets.

Technical basis

Guidelines we work to

ICH M8 (eCTD)Electronic submission standard; implementation varies by authority.
ICH Q12Lifecycle management concepts such as established conditions and post-approval change management protocols.
National variation and renewal regulationsEach authority’s classification of changes and renewal procedures.

What we need from you

Approved dossiers and registration certificates
Details of planned changes
List of registrations with expiry dates
Local agent contacts and responsibilities

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

Market and jurisdiction considerations

Many African and Asian authorities require periodic renewal or re-registration, sometimes with updated data or GMP evidence. Missing renewal dates can interrupt supply, so a clear tracker is essential.

FAQs

Regulatory Submission Support: frequently asked questions

Can you manage registrations in several countries?

Yes. We help maintain a single tracker and coordinate submissions with your local agents.

Do you handle variations?

Yes. We assess each change, determine the filing category per market and prepare the documentation.

Can you speed up review times?

Review times are set by the authority. A complete, well-organised submission avoids preventable delays.

Talk to us about Regulatory Submission Support

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