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Services

Management of establishment license

  • Establishing your company in Switzerland

  • Obtaining, maintaining, changing your operating license

  • Assumption of the role of "Swiss Qualified Person / Responsible person" according to HMG (SR 812.21) / AMBV (SR 812.212.1)

  • Assumption of the role of the deputy "Swiss Qualified Person / Responsible Person" according to HMG (SR 812.21) / AMBV (SR 812.212.1)

  • Communication and interactions with Swissmedic and BAG

  • Assistance with inspection preparations

  • Support in the implementation of new regulations and your projects

  • interim management

Quality management

  • Building up, improving and assessing your quality management system

  • Creating, revising and updating process descriptions, Standard Operator Procedures (SOPs) and Work Instructions

  • Review of Quality Technical Agreements

  • Dossier compliance and market release of batches for the Swiss market

  • Assessment of Manufacturer Product Quality Reviews

  • Conducting audits and self-inspections

  • Management of Change Control, Complaint, Deviation, CAPA

  • Risk Assessment

  • Training and courses

  • Interfaces to pharmacovigilance, medical affairs and regulatory affairs

Regulatory Affairs

  • Support in getting the Marketig Authorisation for you products 

  • Maintenance / lifecycle management of your drug and medical device approvals

  • Management printed packaging / artwork

  • Specialty List (SL)

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