Areas of Expertise

As customer you may rely on an internationally experienced team of regulatory and quality professionals to support you in all aspects of regulatory and quality affairs. Choose from all services of what is needed to succeed in the pharma market.
These include the sectors of:

Regulatory Affairs Management

• Preparation and submission of new marketing authorization applications to Swissmedic
• Life Cycle Management of existing products
  
• Liason with Swissmedic
• Technical writing service (Module 3 & 2.3, ASMF)
• Consulting in submission strategies
• Acting as licence holder
• Control of promotional material, events for compliance with Swiss Regulations
• Support for reimbursement applications
• Due diligence review (dossier)
• In-house regulatory trainings 

Quality Management

• Creation and maintenance of GDP-Quality Management System according to Swiss Regulation, customized according to client needs
• Management of Authority inspections (prepare, attend, follow-up)
• GDP-Audits and self-inspections
• GMP- and GDP- Quality Agreements
• Liaison with pre-wholesaler
• Batch release to Swiss market
• Handling and reporting of adverse events, medical enquiries and local literature reviews
• Complaint, quality defect, deviation and CAPA Management
• Trainings​

Responsible Person Function

• Responsible Person for GDP according to art. 17 Medicinal Products Licencing Ordinance (MPLO)
  
• Responsible Person for Pharmacovigilance art. 65, cipher 3  Therapeutic Products Ordinance (TPO).
• Responsible Person for Promotion according to art. 25  Therapeutic Products Advertising Ordinance (TPAO)

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