What we do, how we deliver it, and why it costs less.
Eight service lines, engaged individually or as a sequenced programme across a market cluster. Each one is scoped, priced and delivered against defined milestones.
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 submitted application, tracked to decision, with the local roles in place.
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: A compliant local position, held and maintained, without you incorporating.
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 registration granted, and the maintenance that keeps it valid.
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: A compliant safety function, without a local hire.
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: Eligibility to actually bid, and a registration that lands before the window rather than after it.
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: A qualified site engaged and activated, without you running the search yourself.
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: A product that can actually be bought in the market it is registered in.
Commercial coordination
Governance across the cluster as it scales.
- Distributor selection and oversight
- Milestone-based engagement structuring
- Cross-border commercial coordination
- Continuity as the portfolio grows
What you get: One relationship across markets instead of a vendor stack you manage.
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 bench
Regulatory, quality and clinical execution is carried by qualified partners 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.
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.