What we do, how we deliver it, and where the cost difference comes from.
Eight service lines, engaged individually or as a sequenced programme across a market cluster. Each is scoped and priced against defined milestones before work begins.
Clinical trial start-up
Getting a study open in a market where you have no entity.
- SAHPRA clinical trial application prepared for the next submission cycle
- Ethics committee submissions and approval tracking
- Site identification, feasibility support and activation
- Import permits and the authorisations that gate study supply
- Local safety contact where one is required
What you get: A clinical trial application prepared to the authority's requirements and lodged in the target submission cycle, ethics submissions lodged, and every authority and ethics query answered and tracked through to the decision. Approval is granted by the authority and the ethics committee.
MAH and Local Technical Representative
Holding the in-country position registration legally requires.
- Marketing Authorisation Holder coordination with licensed local partners
- Local Technical Representative arrangements
- Applicant of record and licence-holder structuring
- Local responsible entity arrangements
- Authority correspondence and standing
What you get: The local roles the market requires identified against the published requirement, candidate licensed parties assessed and their licence and standing verified against documents, the appointment contracted, and the position administered for the life of the mandate.
Product registration and lifecycle
From dossier to a registration that stays standing.
- Dossier adaptation and localisation to CTD or ACTD
- Route selection across national, reliance and continental pathways
- Sameness demonstration and bridging packages
- Variations, renewals and permits
- Post-approval commitment tracking
What you get: A dossier adapted to the authority's format, the route confirmed before filing, the application lodged, and every query and deficiency answered through to the authority's decision, followed by the variations, renewals and post-approval submissions the registration requires. Registrations are granted by the authority.
Pharmacovigilance
The safety obligations attached to every registration.
- Local safety contact arrangements
- Adverse event intake and onward reporting within applicable timelines
- Periodic reporting cycles
- Product complaint handling
What you get: The local safety contact appointed, adverse event intake operating, onward reports submitted within the applicable timelines, periodic reports prepared and lodged, and product complaints logged and processed.
Public sector and donor procurement access
In much of Africa the principal buyer is not the private market. It is ministries of health, central medical stores, and the donor-funded programmes that supply them.
- Public-sector listing requirements per market
- Tender calendars, submission windows and qualification criteria
- Supplier qualification: tax clearance, local registration, prior performance, documentation and language
- Donor and multilateral procurement routes and their eligibility conditions
- Registration timing sequenced backwards from known procurement dates
What you get: The qualification criteria for each buyer identified from the buyer's own published requirements, the qualification documentation assembled and submitted against them, and the regulatory sequence planned backwards from the published procurement calendar. Eligibility is determined by the buyer.
Clinical site identification and placement
Where a study needs an African site, we identify qualified sites and place the work with them, then coordinate activation.
- Site identification against protocol and therapeutic area
- Phase I, bioequivalence and later-phase capability matching
- Feasibility support and capacity confirmation
- Ethics and regulatory start-up coordination
- Activation and in-country study contracting
What you get: Candidate sites identified against the protocol and therapeutic area, capability and capacity assessed against documented criteria, feasibility completed, and start-up and contracting carried through with the sites that accept the study.
Market access and tender
The route from an approved product to a purchasable one.
- Public-sector listing requirements per market
- Tender calendars and submission windows
- Donor and multilateral procurement routes
- Pricing and reimbursement file support
What you get: The listing, pricing and reimbursement requirements identified per market, and the submissions those routes require prepared and lodged. Listing and reimbursement decisions rest with the payer or the listing authority.
Cluster governance and continuity
A single line of accountability as the portfolio grows across markets.
- Distributor selection and oversight
- Milestone-based engagement structuring
- Cross-border commercial coordination
- Continuity as the portfolio grows
What you get: One contracting counterparty across the cluster, the local parties engaged under Veltrion's terms rather than assembled by you, and a single reporting line as the portfolio grows.
The infrastructure behind it
Veltrion is deliberately asset-light. The mandate, the sequencing and the accountability sit centrally. The regulated work is performed by parties licensed to perform it in each market.
The mandate
You contract with one counterpart. One commercial relationship, one point of accountability, one plan across every market in the cluster.
The delivery layer
Regulatory, quality and clinical work is performed by parties qualified to perform it, engaged for the specific market and product, under written terms and confidentiality agreed before any client material moves.
The licensed position
Roles that require a licence are held by parties licensed to hold them in that market. We coordinate and govern that position; we do not claim to be it where we are not.
Where the leverage actually comes from
Not from being cheaper per hour. From changing the shape of the cost.
Scope and fee are confirmed in writing before any work begins. The first engagement is a fixed-fee assessment, a proportion of which is credited against the mandate that follows.
Why this is hard to assemble any other way
Regulatory coordination, commercial contracting and African implementation are normally bought from three different providers under three different contracts. Nobody among them is accountable for the date, and the client carries the integration risk.
The failure points in these markets are as often contractual and governance-related as technical: who holds the registration, what happens to it if the relationship ends, how liability sits between sponsor and local entity, and whether the channel can be governed at all. Those questions are handled inside the mandate rather than passed to a third party. Where legal services are required, you instruct attorneys separately.
In more depth
Detail on the individual service lines and markets, for anyone scoping a specific route rather than a programme.
Tell us the market and the date.
Most of these conversations resolve in one call. If there is no route worth taking, we say so on the call.