OBTAINING PHARMACEUTICAL ESTABLISHMENT LICENSE (PEL/WDL)
Pharmaceutical companies that distribute medicinal products in Switzerland require a Pharmaceutical Establishment License (PEL). Swissmedic issues PEL based on a successful inspection of the Quality System. We prepare the Quality System, either as a “stand alone” or integrated in your already existing international structures and assist you during the inspection to meet Swissmedic standards and pass the inspection.
- Authors SOPs and quality agreements or adapts your already existing ones
- Laisses with Swiss logistic provider, pre-wholesaler and conducts audits
- Prepares application for Pharmaceutical Establishment License
- Communicates with health authorities and inspectors
SERVICES OF RESPONSIBLE PERSON
Swissmedic and four regional cantonal inspectorates carry out regular inspections to maintain your pharmaceutical establishment license. They examine different aspects of the quality performance. We prepare the documentation demonstrating your performance and assist you during the inspection to meet Swissmedic standards and pass the inspection.
- Represents your company during Swissmedic inspection
- Reviews and revises Quality System as required by Swissmedic to maintain PEL
- Provides and maintains access to Swissmedic e-platform
- Conducts Batch Release and all other QA task as required
Target BioScience AG has a year’s long experience in different types of company’s settings and can provide services for small size and complex company’s structures. Detailed information is provided upon request.