The mission of the Quality Assurance team is to promote and embed a strong quality culture within corporate environments. By designing fully customized solutions aligned with each client’s specific needs and regulatory context, the team supports quality processes up to the full outsourcing of the Quality Management System, allowing companies to focus on their core business and innovation activities.
The team offers a comprehensive portfolio of Quality Assurance services, including:
- GxP Quality System design and compliance assessment Design,
- implementation, and maintenance of Quality Management Systems compliant with ISO 9001:2015
- Gap analysis and risk assessment of existing Quality Systems Quality Assurance shop floor support Batch record review and preparation of APR/PQR Management of Change Control, Deviations, and
- CAPAs Management of the GxP documentation lifecycle, including SOPs and quality system records
- Preparation for and support during regulatory inspections and customer or third-party audits
- Execution of internal and supplier audits (GMP/GDP)
- Quality Agreements management and Supply Chain Mapping
- Mock audits and mock inspections, including post-inspection remediation plans GMP training and support on EU GMP Annex 1 requirements Support in defining and implementing the Contamination Control Strategy (CCS)
The fee will be calculated based on the estimated number of days required to provide the services, at an average of €500 per day.
The Quality Assurance team operates across multiple areas, with a particular focus on Life Sciences, Pharmaceuticals, and GxP-regulated industries. The team reserves the right to assess each project individually to determine whether it has the appropriate expertise to support the client’s specific needs. The fee for services is on average €500 per day, depending on the number of days required to deliver the agreed scope.
Prototyping & PoC
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