REGULATORY
Registration assistance
CTD and ACTD dossiers, CPP, free-sale certificates, legalisation and apostille for your authority.
A dossier built to the authority’s format
Getting a product registered in a new market is usually slower than getting it made. Each authority specifies its own dossier format, its own certificate requirements and its own legalisation chain, and a submission that misses any of them goes back to the start of the queue.
We prepare dossiers and supporting documents to your regulatory authority’s format, and coordinate the certificates and legalisation that sit around them.
What is included
- Dossiers in CTD and ACTD format
- Certificate of Pharmaceutical Product (CPP)
- Free-sale certificates and GMP certificates
- Legalisation and apostille
- Product literature and technical documents
- Guidance on the authority’s specific requirements
Where this service earns its place
Manufacturers entering a new market
A dossier built to the authority’s format from the start.
Brand owners expanding a portfolio
Certificates and legalisation coordinated alongside the submission.
Local partners and importers
The documentation an importing authority asks for, prepared once.
Regulatory teams under deadline
Support on the document chain while your team handles the science.
From first enquiry to delivered goods
Enquiry and quote
Send the product, strength, quantity and destination. We reply with availability, landed pricing and the documents your market needs.
Confirm and document
Specification agreed, registration and export paperwork prepared, supply plan confirmed before anything ships.
Source and verify
Product from licensed sources only, with certificate of analysis, batch records and packaging checked before dispatch.
Ship and hand over
Freight booked, cold chain held, documents travelling with the goods, and the temperature record handed over at delivery.
What buyers ask before they commit
Which dossier formats do you prepare?
CTD and ACTD, prepared to the format your regulatory authority specifies. A submission that misses a format requirement goes back to the start of the queue, so the format is settled before writing begins.
What is a CPP, and will I need one?
A Certificate of Pharmaceutical Product, issued in the country of origin to a WHO-recommended format. Most importing authorities ask for one. We confirm which certificates your particular destination requires before the file is assembled.
Do you handle legalisation and apostille?
Yes — apostille where the destination accepts it, and the consular legalisation chain where it does not.
How long does registration take?
The review period is set by the authority, not by us, and varies widely by market and product class. We confirm the current requirement and the expected review period before you commit, rather than quoting a figure that suits the proposal.
Can you advise before we choose a market?
Yes. Knowing what a market will require — dossier format, certificates, legalisation chain — is usually cheaper to find out before the decision than after it.
The rest of the chain
Wholesale distribution
Branded and generic medicines, nutraceuticals and surgicals to hospitals, institutions and distributors.
02Contract manufacturing
Production on lines already built, validated and inspected — under your brand, to your specification.
03Named patient supply
Sourcing, permits, cold chain and delivery for a single identified patient, through their physician.
04Reference listed drugs
Innovator reference and comparator products from the market of origin your filing requires.
05Exports and international supply
Registration, labelling, permits and shelf-life on arrival resolved before a consignment ships.
06Cold chain and supply chain
Validated packing, data logger monitoring and an excursion protocol agreed in advance.
Background reading
How end-to-end pharmaceutical support simplifies healthcare access
Most delays happen in the handoffs between suppliers, not inside them. What end-to-end support actually changes.
Read →Ethical pharmaceutical sourcing: building trust in healthcare supply chains
Falsified medicines enter wherever a legitimate route is slow or expensive. What licensed sourcing requires.
Read →Secure pharmaceutical logistics: protecting medicines from order to delivery
Cold chain failures accumulate in ordinary gaps — collection, storage, transit and handover.
Read →Have a question about registration assistance?
Send us the specifics — the product, the destination, the quantity — and you will get a direct answer rather than a brochure.