For over 20 years, CVO-EUROPE has been developing real expertise in regulatory compliance for life sciences.
Thanks to our monitoring tools and our in-house training policy, our teams benefit from two-fold expertise; technical expertise but also regulatory expertise related to the life sciences industries.
You can see examples of projects and missions that we can do for you below:
For more than 20 years, CVO-EUROPE has been renowned as a compliance expert in the following fields: equipment, utilities, processes, sterility, sterilization, cleaning, computerized systems, software, infrastructures, laboratory systems, computerized systems, analytical methods, etc.
- Validation strategy (VMP, validating procedures, etc.)
- Validation planning and organization (validation plan)
- Risk management, Risk Management Plan (RMP)
- Planning, preparation, execution and conclusion of verifications and qualifications – suppliers (SQ), design (DQ), commissioning (FAT, SAT), installation (IQ), operational (OQ), data migration (MQ), performance (PQ)
- Periodic validation / annual evaluation / trend analysis
- Change control and compliance status management
- Training, audit, assessments,advice
CVO-EUROPE will help you define your data integrity policy so that it complies with regulatory requirements and will suggest a remediation plan as well as the resources needed to implement it.
- Training
- Processes and systems audit
- CAPA plan
- Software application for helping with evaluating risks associated with your data integrity for your processes, procedures, systems
- Guidance for carrying out your remediation plan for ensuring regulatory compliance
For 20 years, CVO-EUROPE has been helping you to ensure that your computer systems are compliant both during the design and validation phases.
- Project management
- Scheduling,
- supervising,
- developing documents (User Requirement Specifications, Functional Specifications, System Design Specifications),
- integration tests,
- acceptance tests
- Tests and validation
- Unit/integration testing,
- acceptance testing,
- validation (DQ, IQ, OQ, PQ, etc.)
- Managing IT processes
- QMS (Quality Management System),
- documentation,
- continued improvement of quality management processes
- Security and risk management
- Risk analysis and management,
- security policy,
- architecture,
- recovery plans
- Computerized systems audit, Supplier audit
- Preparing and conducting audit on site,
- disseminating results
- Training
For more than 20 years, CVO-EUROPE has provided you with concrete support for implementing, optimizing or making your QMS / PQS fully compliant with regulatory standard requirements.
- Quality System Management:
- Quality and process management: policies, guidelines,
procedures, instructions, manuals, operating modes - Job descriptions, training plans
- Risk management, risk register
- Internal audits
- External audits
- Regulatory monitoring
- Quality Assurance
- Quality and process management: policies, guidelines,
- Operational quality:
- Deviations, OOS, OOE, OOT and CAPA management
- Complaint management
- Change control
- Data Integrity analysis and remediation plan
- Metrology and preventive maintenance
- Periodic validation and qualification
- Regulatory training and refresh (GMP, etc.)
- E-learning
- Face to face training
- Training using games
The CVO-EUROPE’s team of laboratory experts will enable you to ensure efficient checks and compliance for your laboratory.
- Laboratory equipment qualification and computerized systems validation.
- Design and validation,
- development documentation (URS, FS, SDS),
- system configuration,
- validation strategy (Validation Master Plan, risk analysis),
- test plans,
- execution/checking tests,
- CAPA, IQ, OQ, PQ, etc.
- Validation of methods
- Laboratory activities
- Analysis,
- preparing and reviewing the files for inspection,
- quality control,
- managing and analysing Out of Specifications (OOS),
- metrology (controls)
- Statistics studies
- Training
- Audits
Our experts in regulatory affairs enable you to carry out your regulatory strategies productively, they ensure regulatory compliance and submitting your files and variations as early as possible (reduced lead time and time to market).
- Managing variations and recordings – Marketing Authorization Application (MAA)
- Site Master File management
- Vigilance management
- Authorization for clinical trials
- Advertising management
- Managing product life cycles
- Relations with health authorities
- Training
- Audits
- Etc.
For more than 20 years, CVO-EUROPE has been renowned as an engineering and compliance expert in the following fields:
– processes (biotechnology, API, oral and solid forms, sterile, primary and secondary packaging, warehouse…)
– utilities (HVAC, classified area, WFI, PW, SIP, CIP…)
– computerized systems (ERP, LIMS, EDMS, EBR, QMS, MES, WMS, serialization…) / automated systems (SCADA, DCS, AMS, EMS, BMS…); software, infrastructure, laboratory systems (IPC, QC, R&D)
Our experts ensure you guaranteed compliance with the following missions:
- Program management
- Project management Officer (PMO)
- Feasibility study, technical and budgetary evaluations, master plans
- Conceptual design / Basic design
- Requirement definition (URS, SOW – Statement of Work)
- Tender documents (RFI, RFP, RFQ)
- Detailed design: functional and technical specifications
- Procurement
- Construction and installation follow-up
- FAT, SAT
- As-built records
- Commissioning, qualification, process validation
- Production, maintenance and metrology handover
- Optimization and maintenance
- Training, audits, assessments, advice, technical expertise
Our experts are there to guide you right from the preclinical and clinical studies through to drawing up regulatory files and submitting them. They guarantee your studies will be compliant.
- Managing preclinical study (strategy and planning)
- Managing projects for a clinical study
- Set-up, monitoring and closure
- Clinical data management
- eCRF,
- CFR design,
- coherence controls programs,
- amendment management,
- data base management
- Regulatory Affairs:
- authorization,
- submission,
- marketing,
- writing and submitting MAA/NDA,
- regulatory files/eCTD
Our experts’ two-fold expertise for processes and regulations in terms of production, laboratory and R&D, guarantees making your process optimal whilst also remaining compliant.
- Building strong foundations for your performance strategy
- Training for the Lean Six Sigma concepts
- Involving your managers and your teams in carrying out changes
- Audits
- Etc.
Our training center
To make sure our clients have access to local service, we have set up 6 training centers, in France, Belgium and Switzerland.