Closed Loop Quality Ltd

Looking for flexible, independent auditors to provide high-quality results? Does your current Quality Management System (QMS) need a fresh perspective? Or maybe extra support for inspection preparation?

Closed Loop Quality Ltd. can help. With over 17 years of international Good Clinical Practice (GCP) / Good Document Practice (GDP) audit experience, we understand quality needs to be right-first-time. Our organisation holds formal accreditation in Project Management with the Association for Project Management (APM), as well as membership with the Research Quality Association (RQA).

We offer a wide range of QA services (both on-site and remote), as follows:

1. GCP/GDP Auditing:
- Clinical study audits (site, study management)
- System and process audits (local and global)
- Vendor audits (CROs, SMOs, AROs, and Phase I units)
- For-cause audit performance
- Corrective and Preventive Action (CAPA) management

2. Regulatory Authority Inspections:
- Inspection support, preparation and facilitation
- Mock inspection performance
- Inspection coaching

3. QMS Consultancy:
- System/procedure gap analysis
- Standard Operating Procedure (SOP) review

4. Network access to international experienced QA professionals in varied GxP disciplines (GMP, GLP, CSV, and GvP)

To explore how Closed Loop Quality Ltd. can close your organisation's quality loop, contact Iain Pulley for information.

Availability for Work

Worldwide, Remote, Africa, Asia, Australasia, Europe, North America, South America

Area(s) of Expertise

Auditing, Good Clinical Practice (GCP), Quality Management Systems (QMS), Inspection Preparation

Contact Details

64 Brixham Road, Reading, Berkshire, RG2 7RB, United Kingdom

Telephone:  +44 778 69 813 96

E-mail:  iain.pulley@closedloopquality.com

Website:  http://www.closedloopquality.com

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