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Learn more →Wholesale distribution of medicinal products · tiger.PHARMA
Build GDP-compliant pharmaceutical wholesale operations
tiger.PHARMA supports new and established pharmaceutical wholesalers with German wholesale authorisation, GDP QMS, the Responsible Person, audits, warehousing, transport, availability, pharma ERP and MSV3.
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Pharmaceutical wholesale distributors
GDP.secure.QMS.smart — pharma expertise with a clear operational focus.
MSV3 ERP & WMS integration
Expertise, data and delivery combined in a resilient solution.
Learn more →MSV3 operations & pharmacy onboarding
Expertise, data and delivery combined in a resilient solution.
Learn more →Quality management system (QMS) & Good Distribution Practice (GDP)
Expertise, data and delivery combined in a resilient solution.
Learn more →GDP audit & inspection readiness
Expertise, data and delivery combined in a resilient solution.
Learn more →Wholesale authorisation for medicinal products
Expertise, data and delivery combined in a resilient solution.
Learn more →Supplier & customer qualification
Expertise, data and delivery combined in a resilient solution.
Learn more →Returns, recalls & falsification protection
Expertise, data and delivery combined in a resilient solution.
Learn more →Transport and warehouse integration
Expertise, data and delivery combined in a resilient solution.
Learn more →Pharma ERP, inventory management & securPharm
Expertise, data and delivery combined in a resilient solution.
Learn more →External Responsible Person (RP)
Expertise, data and delivery combined in a resilient solution.
Learn more →Medicines procurement & availability
Expertise, data and delivery combined in a resilient solution.
Learn more →Pharmaceutical wholesale · German authorisation · GDP · MSV3
Pharmaceutical wholesale: authorisation, GDP and operations
tiger.PHARMA supports new and established pharmaceutical wholesalers with German wholesale authorisation, GDP QMS, the Responsible Person, audits, warehousing, transport, availability, pharma ERP and MSV3.
A pharmaceutical wholesale business must manage authorisation, quality, product flow and data as one operating model. We translate regulatory requirements into practical processes, systems, accountability and a controlled go-live or improvement programme.
tiger.PHARMA Kompetenz
Topics we master
Set up pharmaceutical wholesale or improve an existing operation
A start-up needs a clear business model, activity scope, site, QMS, Responsible Person and inspection path. Established wholesalers more often need remediation, scaling, digital integration and sustained inspection readiness.
- Define products, customers, activities and flows
- Gap assessment against licence and actual operations
- Roadmap for premises, systems, qualification and go-live
- Prioritised improvement programme for live operations
German wholesale authorisation
The German authorisation is prepared for a specific site and scope of activity. The application, evidence and real operating model must be consistent before regulated wholesale begins.
- Authorised activities and medicinal products
- Site, premises, equipment and organisation
- Competent and reliable Responsible Person
- Application dossier, authority dialogue and inspection readiness
GDP QMS for pharmaceutical wholesale
An effective GDP QMS controls decisions, not only documents. It connects procurement, receipt, storage, ordering, dispatch, returns, deviations, CAPA, recalls and outsourced activities.
- Quality manual, SOP architecture and document control
- Risk, deviation, change and CAPA management
- Training, self-inspection and management review
- Data integrity and inspection-ready evidence
Responsible Person and governance
The Responsible Person needs time, access, independence and documented authority. Management, quality, warehouse, procurement, IT and external partners are linked through clear governance.
- Duties, authority and escalation rights
- Deputy arrangements, presence and continuity
- Approval of suppliers, customers, returns and deviations
- Regular quality and management reporting
Qualify suppliers, customers and service providers
The wholesaler verifies authorised sources and recipients. Warehouse providers, carriers, IT suppliers and other critical providers are approved and monitored according to risk.
- Check licences, certificates and registers
- Control authorised recipients and delivery addresses
- Quality agreements and audit strategy
- Periodic review, blocking and escalation
Warehousing, transport and temperature
Zones, routes, vehicles, packaging and monitoring are qualified for product and risk. Every excursion must result in a documented quality decision.
- Warehouse temperature mapping and qualification
- Transport and packaging qualification
- Monitoring, alarms, calibration and data review
- Quarantine, blocked stock and excursion assessment
ERP, WMS, MSV3 and securPharm
Digital systems connect batches, PZN, status, customer authorisation, stock, orders and dispatch. MSV3 opens the pharmacy order channel while ERP and WMS control the underlying product and evidence flow.
- PZN, batch, serial number and master data
- MSV3 server, prices, availability and responses
- ERP/WMS integration and controlled interfaces
- securPharm, traceability, roles and audit trail
Audit, inspection and CAPA
Self-inspection, mock audit and authority inspection use the same evidence base. Findings are risk-ranked, investigated, corrected and checked for effectiveness.
- GDP checklist and risk-based audit plan
- Interview, document and process readiness
- Finding, root cause, CAPA and due dates
- Effectiveness review and sustained readiness
FAQ
Frequently asked questions
How do you set up a pharmaceutical wholesale business in Germany?
Define the business model, activities, products, customers, site and product flows first. Then establish the Responsible Person, premises, GDP QMS, qualification controls, logistics, IT, application dossier and inspection readiness.
Which authorisation does a pharmaceutical wholesaler need in Germany?
Regulated wholesale of medicinal products generally requires a wholesale distribution authorisation under section 52a of the German Medicines Act. Its scope and site must match actual activities.
What is the difference between wholesale authorisation and a GDP certificate?
The authorisation permits the defined wholesale activities. An authority-issued GDP certificate records the outcome and scope of a GDP inspection. A private audit certificate replaces neither.
What does the authority inspect?
The authority examines the application scope, Responsible Person, premises, equipment, QMS, records, supply chain, storage, transport and the organisation's ability to comply in practice.
What does the Responsible Person do?
The RP ensures that the QMS is implemented and maintained and that authorised activities are conducted correctly. This requires documented authority, access and effective involvement.
Which SOPs does a wholesaler need?
The set depends on the operation. Typical subjects include document control, training, suppliers, customers, receipt, storage, dispatch, temperature, returns, complaints, recalls, falsification, deviations, CAPA, change control and self-inspection.
How long does German wholesale authorisation take?
Timing depends on dossier completeness, site readiness, construction, QMS maturity, the RP and inspection scheduling. A reliable timeline starts with a gap and feasibility assessment.
What does it cost to set up pharmaceutical wholesale?
Cost depends on scope, premises, equipment, people, RP, QMS, qualification, IT, transport and inventory. Separate capital expenditure, operating cost and working capital.
Which systems does a pharmaceutical wholesaler need?
The operation needs controlled master data, procurement, stock, batch, customer, order, dispatch and traceability processes. ERP, WMS, securPharm, MSV3 and validated interfaces may be required.
Does tiger.PHARMA support existing wholesalers?
Yes. Services include GDP gap assessments, QMS remediation, external RP, audit readiness, partner qualification, warehouse and transport integration, ERP/MSV3 projects and availability management.
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