Efor provides its Life Sciences industry clients with concrete support for the implementation, optimization, and compliance of their organizations and quality systems with regulatory and normative requirements in Europe and internationally.
Our expertise Quality Assurance
System Quality Assurance
We provide pragmatic and concrete advice on risk analysis, post-marketing surveillance, deviation and CAPA management, and regulatory monitoring, helping our clients achieve the appropriate level of compliance expected by competent authorities.
Finally, our teams of certified auditors provide their expertise in the preparation of audits by notified bodies (GMED, TUV,…), inspections (FDA, ANSM, PMDA, MHRA), or during critical subcontractor audits.
Operational Quality Assurance
- Deviation and CAPA management
- Complaint management
- Change control management
- Data integrity analysis and remediation plan
- Project management for digitalization (implementation and validation of quality software, digitization of batch records, etc.)
- QHSE expertise (Ergonomics, Certifications, etc.)
Supplier Quality Assurance
- Management, analysis, and approval of supplier integration or change requests.
- Implementation and maintenance of Quality Agreements
- Management of investigations and participation in the analysis of causes of non-conformities
- Support in the improvement or management of CAPA systems implemented to resolve supplier non-conformities.
- Participation in periodic supplier evaluation committees
- Management of continuous improvement activities focused on supplier quality
Our Audit Center also offers partial or complete outsourcing solutions for supplier quality assurance activities.
- Transition management
- Organization and life of the laboratory in accordance with GMP and HSE rules
- QC release, maintaining and monitoring deadlines, implementation and monitoring of KPIs
- Management and monitoring of OOS, OOT, Deviations and CAPA
- Backlog analysis processing
- Analytical assistance to production
- Development, validation and transfer of analytical methods
- Support for transformation projects (implementation and validation of LIMS, strategy for standardization of analytical methods for digitalization, etc.)
SystemThe implementation and certification of a Quality Management System (QMS) according to ISO 13485 are key steps in accessing the European market. Drawing on various experiences gained, our experts support our clients in structuring and maintaining their QMS in accordance with the expectations of competent authorities.
Non-complianceIn the pharmaceutical industry, the management of non-compliances (NC) is essential in order to comply with GMP requirements. Our experts have been able to provide their skills to ensure the optimal management of NCs and associated CAPAs before and after regulatory authorities inspections.
TransitionIn case of events impacting our clients’ Quality Control laboratories, our experts intervene as transition managers to ensure operational management, release of finished products, or to lead transformation or digitization projects.
SuppliersSupplier management is a key element in meeting regulatory requirements for traceability. Our experts have been able to provide their skills in qualifying and auditing our clients’ critical suppliers, as well as in the establishment and management of Quality Agreements.
LaboratoryFor a cosmetics industry client, our experts were able to perform a diagnostic of the ex-vivo testing facility and propose an action plan to ensure the acquisition of GLP certification.
« We aim to consolidate our position as specialists in securing healthcare products ».
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