Product registration coordination
Structured coordination of the full registration pathway — from document collation to submission support and authority correspondence, aligned with your local market partner.
Product Registration & Regulatory Support
Pharmaceutical product registration, coordinated across markets.
KOIT coordinates pharmaceutical product registration and regulatory requirements across international markets — working with manufacturers, regulatory consultants and local market partners to move products from dossier to approval.
What we cover
Registration support across the product lifecycle.
Dossier & documentation support
CTD-aligned dossier compilation guidance, gap review of manufacturer documentation, and alignment of the regulatory package for international submissions.
GMP & manufacturing documentation
Coordination of GMP certificates, COPP/CPP, site master files, stability data and other quality documentation required by registration authorities.
Local regulatory partner coordination
Ongoing liaison between manufacturers, MAHs, regulatory consultants and local agents throughout the product lifecycle in each market.
Variations & renewals
Support for post-approval variations, renewals and lifecycle maintenance so registrations stay current as products and requirements evolve.
Regulatory gap coordination
Identification and closure of documentation gaps between source dossiers and destination-market requirements before submission.
Process
How a registration engagement runs.
- 1
Share the product, dosage form and target-market context
- 2
KOIT reviews the existing dossier and identifies documentation gaps
- 3
Manufacturer documentation and GMP evidence coordinated under confidentiality
- 4
Regulatory package aligned with the local partner's submission requirements
- 5
Submission support and authority query responses coordinated through KOIT
- 6
Post-approval variations and renewals managed across the product lifecycle
Who it's for
Built for cross-border partners.
- Importers and distributors registering products in their markets
- Marketing authorization holders needing registration support
- Pharmaceutical manufacturers entering new export markets
- Pharmaceutical companies without in-country regulatory presence
- Institutional and tender buyers requiring registered products
- Brands partnering with KOIT for contract-manufactured supply
Therapeutic coverage
Registration support across KOIT's therapeutic portfolio.
CardiologyAnti-diabeticAnti-infectivesGastroenterologyRespiratoryPain & inflammationCNSOncologyNutraceuticalsDermatology
Explore the full breakdown on the Therapeutic Areas page .
Related capabilities
Registration is one part of the engagement.
Solutions
Sourcing, merchant trade, contract manufacturing and regulatory coordination — the full capability set.
ExploreManufacturing Network
The WHO-GMP, EU-GMP and PIC/S certified sites behind the products we register.
ExploreSourcing from India
How KOIT connects buyers with qualified Indian pharmaceutical manufacturers.
ExploreFAQ
Common questions about registration support.
Is KOIT a regulatory affairs consultancy?
No. KOIT is an international pharmaceutical business development company. We coordinate registration and regulatory requirements across manufacturers, regulatory consultants and local market partners — the registration itself is filed by the appropriate local entity or MAH.
Which markets can KOIT support product registration in?
We coordinate registration support across the markets where we are active — including Mexico, Peru, the Philippines, Ghana and Nigeria — and across our wider growth network in Latin America, Africa, South-East Asia and CIS regions. Requirements vary by market and are confirmed per project.
What documentation is typically needed to start a registration?
Typically a CTD-format dossier, GMP certification for the manufacturing site, COPP/CPP where applicable, stability data and product specifications. We review what exists, identify gaps and coordinate closure with the manufacturing site.
Does KOIT prepare the dossier itself?
We guide dossier compilation and align the manufacturer documentation with the destination market's requirements. Technical authoring remains with the manufacturer and, where engaged, specialist regulatory consultants — we coordinate the complete package.
Who holds the marketing authorization?
That depends on the market and engagement structure. Registrations are commonly held by the local distributor, a designated MAH or the manufacturer's local entity. We help structure the arrangement that best fits your commercial model.
Can KOIT support variations and renewals after approval?
Yes. Post-approval lifecycle management — variations, renewals and ongoing regulatory correspondence — is part of our coordination scope for products we support.
Planning a registration?
Talk to us about your product and target market.
Share the product and market context — we'll come back within one business day with the right registration and regulatory path.