Our Support Services

Acting as Regulatory Affairs Specialist (MA-Applications, Variations, Life-Cycle Management) for third parties and clients from the pharmaceutical industry.

• Preparation and submission of all types of Marketing Authorisation Applications for Switzerland (Swissmedic) (new registrations, line extensions, etc.)
• Consulting of the overall registration strategy based on current regulatory aspects
• Constructive analysis and completion of an existing application file
• Answering inquiries from the authorities (Response to Questions based on List of Questions)
• Maintenance of a Marketing Authorisations (full Life-Cycle Management)
• Preparation of SmPC (patient leaflet and professional product information) based on available scientific data
• Preparation of PMS reports for the competent regulatory authorities
• Literature searches with preparation and summary of data
• Preparation of scientific reports (e.g. EU-compliant expert summaries)
  

Acting as Qualified Person (Responsible Person, fvP) including Deputies for third parties and clients from the pharmaceutical industry.

• Preparations and submission of an application for an establishment license according the needs of a start-up company or a new Swiss affiliate of a foreign company
• Building up the quality management system (Quality Management Handbook, Quality Manual)
• Revision of an existing quality management system (Quality Manual, SOPs, Forms etc.)
• Preparation of Quality Technical Agreements (QTAs)
• GxP-conform process optimisation (GNP /GDP / GVP)
• general regulatory, technical and scientific support (GMP / GDP / GVP)
• support for quality control / quality assurance (QC/QA)
• GDP support (warehousing, logistics)
• Support in all Quality Issues (handling of complaints, deviations, recalls, CAPA etc.)

GMP- and/or GDP-Audits (as certified GMP- and GDP-Auditors)

Acting as certified GMP- and GDP-auditors (as Lead Auditor or as Co-Auditor) for third parties and clients from the pharmaceutical industry.

• Performing Audits of national (local) and/or international sites involved in the supply chain as Lead Auditor or as Co-Auditor (Audit Plan, Audit, Audit Report, supervision and control of CAPA etc. until the audit is closed)

Swissmedic Inspections

• Support during preparation of Swissmedic inspections (including attendance and follow-up support)
• Carry out a pre-inspection as preparation