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Project examples from our RQM service catalogue

Our mission and driving force is to provide clients with senior-level QA expertise and hands-on support in their quality challenges along the entire drug life cycle, and contributing to their continued success and growth as a trusted and reliable business partner in all quality matters.

Interim Management & External Quality Leadership

  • External Qualified Person (FvP) for medium- and large-scale pharmaceutical company affiliates in Switzerland, covering local market release, distribution, and quality system management activities.

    Interim management of the QA department in the local affiliate of a multinational pharmaceutical company, assuming full responsibility for the maintenance of the quality system, and staff oversight.

Project Championship for Transformational Quality Projects

  • Project management for the technology transfer of a clinical phase CART process to international CMOs, covering process transfer, validation, regulatory submission, and commercial launch.

  • Redesign of the supplier qualification process and supporting systems in a major manufacturing site of a large-scale pharmaceutical company, including gap analysis and implementation of the corresponding remediation plan.

  • Support of distribution service providers in the implementation of the revised EU GDP guideline, including qualification of storage facilities and validation of supporting transport processes.

Operational GxP support

  • Integral release management for CMO supplies at a multinational biopharmaceutical company.

  • Change management for a major sterile manufacturing unit at a large pharmaceutical company.

  • External Drug Safety Officer supporting country commercial operations of a medium-size international pharmaceutical company.

  • Support of a medium-size pharma company in redesigning their logistical processes to meet applicable FDA requirements.

  • SOP creation supporting a new peptide production facility at a major biopharmaceutical company.

  • QMS and controlled document review for a global CRO, aiming at audit/inspection readiness.