At a glance
Choose a Swiss MAH partner by testing the exact legal entity and operating model, not the brand or service list. Confirm Swiss presence, relevant establishment-licence activities, named regulatory, quality and pharmacovigilance roles, product and supply-chain fit, data access, oversight and a workable exit. SwissGMDP can verify published licence information, but it does not prove capacity or service quality. The best candidate is the one whose evidence matches your product, risks and intended Swiss flow.
Key takeaways
- Define the mandate before comparing providers: holder only, regulated operations, or an integrated commercial model.
- Verify the exact contracting entity, licensed activities and sites rather than relying on a group brand.
- Compare named people, decision rights, records, oversight and continuity, not feature lists alone.
- Negotiate dossier, safety, quality, inventory and transfer-out rights before the relationship begins.
What must be defined before approaching a Swiss MAH?
Start with the product, regulatory status and intended physical flow. State whether you need only an eligible holder, or also regulatory lifecycle work, an RPV and deputy, market release, import, storage, distribution, reimbursement support or commercial operations. A candidate cannot be assessed fairly if each proposal assumes a different mandate.
Separate legal accountability from task performance. One organisation may offer several functions, while specialised parties may also work together. The decision is whether licence scope, agreements, data flow and authority make the complete model coherent. A shorter supplier list is useful only when it does not hide gaps or unchecked subcontractors.
Which evidence distinguishes a qualified candidate from a polished proposal?
Ask for the exact name of the contracting entity and intended authorisation holder. Compare it with the commercial register information and SwissGMDP record. Confirm which sites and activities are covered. The phrase Swissmedic licensed is too broad because import, wholesale and market-release scopes answer different questions.
The evidence should be current and product-relevant. A public licence entry proves published regulatory status, not available capacity, inspection performance, product-category experience, commercial suitability or freedom from portfolio conflicts. Those points need separate diligence and contractual evidence.
| Test | Evidence to request | Why it matters | Red flag |
|---|---|---|---|
| Legal entity | Exact holder and contracting name | Authorisations and licences attach to a legal entity | Only a group brand is named |
| Licence scope | SwissGMDP record, activities and sites | The scope must fit import, wholesale and release | Swissmedic licensed without details |
| Responsible people | Named RP, RPV, deputies and availability | Critical decisions need qualified coverage | Unnamed team or no backup |
| Quality system | Agreements, deviations, CAPA, complaints, recalls and audits | Outsourcing requires documented control | No audit right or hidden subcontractors |
| Dossier and data | eCTD custody, source access, export and migration format | The sponsor needs continuity and transfer readiness | Provider claims exclusive ownership |
| Supply model | Importer, storage, release and customer flow | Physical flow must match licensed activities | Commercial design precedes licence review |
| Conflicts | Portfolio screen and escalation rights | Safety and quality decisions need independence | Commercial approval can block action |
| Exit | Transfer cooperation, records, data migration and inventory clauses | A future holder change moves obligations as well as rights | Punitive or unclear handover terms |
How should you assess the people and governance behind the licence?
Meet the people who would hold decision authority, not only the sales team. Ask who reviews regulatory changes, who makes Swiss market release, who serves as RPV and deputy, and who can act during absence or an urgent quality or safety event. Verify official-language capability and the link to the global dossier and safety systems.
Then test governance with scenarios. Ask how a serious quality defect is escalated, how a global safety signal reaches the Swiss RPV, how a batch is held, and who may initiate a recall. The answers should match procedures, agreements and records. An organisation chart without decision rights is not an operating model.
What should the contract protect from the first day?
The agreements should allocate tasks, retained decisions, service levels, records, data security, audit, deviations, CAPA, change control, subcontractors and escalation. They should also state who owns the eCTD lifecycle, safety data, quality records and regulatory correspondence, and in which usable format the sponsor can obtain them.
Plan for exit before appointment. A later transfer depends on current dossiers, PV history, batch and GMP records, artwork, product information, inventory status and cooperation between holders. Clear migration support and reasonable access rights reduce dependency. They do not guarantee a transfer date or uninterrupted supply, but they make a controlled project possible.
How can candidates be compared without a misleading score?
Use pass or fail gates for legal eligibility, required licence scope, named responsible roles, product-specific capability and data access. Score only the factors where tradeoffs are legitimate, such as integration, language coverage, reporting, systems, commercial support and cost structure. A low fee cannot compensate for a failed licence or governance gate.
Record each conclusion with its evidence, date and owner. Our suggested method is a traffic-light worksheet followed by a risk meeting with regulatory, quality, PV, supply, legal and commercial stakeholders. This is a purchasing method, not a Swissmedic qualification or certification.
What makes a useful first brief for a specialist introduction?
Provide a non-confidential summary of the company, product class, current authorisation territories, intended Swiss route, dossier status, manufacturing and supply model, reimbursement objective and target planning window. State which functions are already covered and which need an external partner.
Do not send patient data, individual safety reports or a confidential dossier through a general enquiry form. A first review should identify the specialist profile and questions to resolve, not make a regulatory determination. Detailed records can follow through an appropriate confidential channel with the selected external specialist.
MAH / CH
Swiss MAH partner due-diligence checklist
Record the evidence, date and reviewer for each item before making a partner decision.
- Define the required mandate and separate mandatory from optional functions.
- Verify the exact legal entity, Swiss presence, licensed activities and sites.
- Meet the named RP, RPV, deputies and regulatory lead.
- Test quality, PV and recall governance with practical scenarios.
- Confirm dossier, safety, quality and batch-record access and ownership.
- Map importer, market release, storage, distribution and customer flow.
- Screen product and portfolio conflicts and decision independence.
- Agree audit, subcontracting, transition and transfer-out rights.
Continue exploring
MAH holdingQuestions before your next step
Does SwissGMDP prove that a company is a good MAH partner?
No. SwissGMDP helps verify published establishment-licence holders, sites and activity scopes. It does not prove capacity, service quality, product experience, acceptable conflicts or commercial fit. Use it as one regulatory check within wider due diligence.
Should one partner provide every Swiss function?
Not necessarily. One integrated partner can reduce interfaces, while specialised providers can offer depth or preserve commercial flexibility. Compare the complete legal and operating model, including licence scopes, agreements, decision rights, data flow and accountability.
What should we ask about the RPV model?
Ask for the named RPV and qualified deputy, qualifications, availability, official-language capability, intake and reporting routes, access to global safety information, quality system, oversight metrics, audits, escalation and business continuity.
Can a provider claim ownership of our regulatory dossier?
Contractual rights can vary, so the sponsor should settle custody, access, use, export format and transfer support before appointment. A holder needs the records to perform its duties, but avoid an arrangement that prevents lawful oversight or a future controlled transfer.
Should price be part of the first comparison?
Yes, after mandatory legal and governance gates pass. Compare scope assumptions, recurring and event-based fees, pass-through costs, change control and exit costs. Do not treat the lowest headline price as evidence that the required licensed and accountable work is covered.
Sources and further reading
- Federal Act on Medicinal Products and Medical Devices
- Ordinance on Licensing in the Medicinal Products Sector
- SwissGMDP public database
- Swissmedic requirements for the Responsible Person for Pharmacovigilance
- Swissmedic: market release with a pre-wholesaler
Independent editorial information for business planning. This is not regulatory or legal advice. Current official guidance prevails; any external specialist introduction is discussed with you first. Please do not send patient data or confidential dossiers.
Free first review
Prepare a comparable brief before meeting candidates
Send a non-confidential summary of your company, product stage and specific question. We review your enquiry and discuss any specialist introduction with you first.
