Clinical Quality Assurance Company

The CQA Company™ is a division of The CLINICAL TRIAL Company™ (TCTC), a privately owned full-service clinical research provider formed in 2002. Our philosophy is one of teamwork, positivity, communication, responsibility and adding value. The CQA Company™ has evolved from an internal resource to a provider of Clinical Quality services to 6 of the top 10 Pharma companies amongst many other satisfied clients.

The CQA Company™ operates under the guidance of a Qualified Person (IMP) and experienced QA professionals from all areas of the healthcare industry. The CQA Company’s™ success has been achieved through recruitment of high calibre staff and also through development of The CQA Company’s™ own employees.

The CQA Company™ team operational personnel are available to augment external organisations through the provision of external QA support which includes:

• Inspection readiness.
• Staff training.
• Internal and external clinical and vendor audits (GCP, GPvP, GLP and GMP).
• Statutory GxP preparation and inspection (FDA, EMEA, MHRA etc.).
• Quality Management System development.
• Review of quality systems and legacy operations.
• Standard Operating Procedure evaluation and generation.
• Process mapping.
• Documentation management.
• QP services.

We do not offer a theoretical approach to Quality Management, auditing and reviews; instead all of our personnel have direct, hands on experience of Clinical Quality Assurance and ICH GCP with the ability to provide a real world insight into the role. The CQA Company™ is that clients are able to access a live QA function rather than a theoretical consultancy. In effect, clients “borrow” fully operational personnel with the flexibility they would expect from their own staff.

The CQA Company™ operates an ISO 9001 quality system which further supports our company philosophy of performing high quality training for our clients.

The CQA Company™ has enjoyed a high level of repeat business from existing clients, which is testament to our commitment to efficient, flexible, responsive and quality service.

TCTC Group is headquartered in Knutsford, Cheshire, UK with regional offices in Stirling and Munich (Germany). TCTC Group is also incorporated in the USA (California), Canada (Montreal), Singapore and Australia (Sydney). TCTC Group has additional operating divisions covering all aspects of drug development including The CRA Company™, The Regulatory Affairs Company™, The CNS Company™, and The Clinical Training Company™.

 

Availability for Work

Worldwide

Areas of Expertise

GxPs- Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GcLP), Pharmacovigilance (GVP), Good Manufacturing Practice (GMP/cGMP), Good Distribution Practice (GDP).  Auditing-Audits- Archiving, CRO, Clinical Study Report (CSR), Company, For Cause , IT Systems, Investigator Site, Site Management Organizations, First in Man , Healthy volunteers, Paediatrics, Phase I-IV , Clinical study Report, Clinical Site , Sponsor Oversight, Systems, Vendor , Clinical Safety, Central Laboratories and due diligence.  Computer System Validation (CSV), Computing, Contracts, Technical Agreements, ISO-ISO:13485, ISO:14155, ISO:15189, ISO:17025, ISO:19011, ISO23640, ISO:9000, ISO:9001, ISO:9004, ISO31000, ISO:9001 Implementation, Quality Improvement, Information Security, Inspection Preparation (FDA, EMA HC, EU CAs), Medical Devices, In-vitro diagnostic (IVD) devices, Quality Management Systems (QMS), Quality Risk Management (QRM), Regulatory Affairs, Standard Operating Procedures (SOPs), Training, Gap analysis and Process Mapping.  Regulatory Inspection Preparation & Hosting.

 

Contact Details

Ewan Campbell
Mere View Barn, Park Lane, Pickmere, WA16 0LG

Telephone: +44 (0) 1565 733722

Fax: +44 (0) 1565 732949

E-mail: info@thecqacompany.com

Website: www.thecqacompany.com

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