Service area
Regulatory services for pharmaceutical registration
Turning complex, country-specific requirements into a clear route to submission is the core of our regulatory work. We prepare and review dossiers, API documentation and labelling, coordinate submissions with you or your local partner, and help you respond when authorities raise questions — with a particular focus on markets in Africa and Asia.
Services in this area
5 defined services
Each service has a clear scope, deliverables and list of the information we need. Choose a service for details.
CTD & ACTD Dossiers
Dossiers compiled in ICH CTD or ASEAN ACTD format, adapted to each target market’s regional requirements.
API Documentation & DMF
Drug master files, ASMFs, open and restricted parts and API technical packages for finished-product applicants.
Label, Artwork & Translation
Market-specific review of labels, cartons, leaflets and artwork — including translations — against regulatory requirements.
Deficiency & Query Handling
Structured, evidence-based responses to deficiency letters and authority queries, coordinated across your technical teams.
Regulatory Submission Support
Submission planning, publishing, tracking, variations, renewals and re-registrations across your target markets.
Typical situations
When companies come to us
Registering a product in a new country
Adapt your dossier to the target authority’s format and requirements.
Supporting customers with API documentation
Provide DMFs, open parts and technical packages that finished-product applicants need.
Labels and artwork for export
Prepare compliant labelling for each market, including translations.
A deficiency letter has arrived
Respond clearly and completely within the authority’s deadline.
Keeping registrations alive
Variations, renewals and re-registrations across a portfolio of markets.
Preparing a submission package
Compile, check and publish dossiers in the required format.
Our approach
How we work in this area
Every engagement follows a documented sequence, so your team and reviewers can trace each conclusion back to its data.
- GroundworkConfirm the regulatory pathway, local requirements and responsibilities (applicant, local agent, manufacturer).
- Pre-registrationGap analysis of existing documents and plan for any missing data.
- Registration and dossierDossier compilation, labelling, submission support and tracking.
- Query handlingCoordinated, evidence-based responses to deficiency letters.
- Post-registrationVariations, renewals, re-registrations and lifecycle maintenance.
FAQs
Regulatory Services: frequently asked questions
Do you submit dossiers on our behalf?
Many authorities require the submission to be made by the applicant, marketing authorisation holder or a locally registered agent. We prepare and check the submission package and coordinate with whoever is authorised to submit.
Can you guarantee approval or a timeline?
No. Approval decisions and review timelines are set by the authority and depend on the product, the procedure and the completeness of the data. We focus on submitting a complete, well-organised file to minimise avoidable delays.
Which markets do you support?
Our focus is on markets in Africa and Asia, alongside dossiers prepared to ICH CTD standards. Tell us your target countries and we will confirm what we can support and how.
Do you work with local agents?
Yes. In many markets a local agent or importer is required. We work with your appointed agent or can help you understand what the agent’s role should be.
Not sure which service fits?
Describe your product and the question you need answered. We will recommend the right scope — or tell you if it is outside ours.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST