Omnia Quae

Omnia Quae are a bespoke independent consultancy proud to offer a broad variety of Quality Assurance and Quality Management System services.

Core services include:

• Audits (Investigator Site, CRO, Vendor and electronic solutions e.g. CTMS, eTMF and IVRS).
• Regulatory Inspection Assistance including conduct of GCP and Pharmacovigilance Regulatory Inspection readiness (mock) audits and assistance prior to and during inspections.
• Quality Management System assistance including QMS review and implementation, creation of policies and SOPs, CAPA system management and implementation.
• Resource Provision including providing cover for various QA roles. Training including GCP and regulatory inspections.

Availability for Work

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

Areas of Expertise

Auditing, Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Information Technology (IT), Quality Management Systems (QMS), Quality Risk Management (QRM), Standard Operating Procedures (SOPs), Inspection Preparation

Contact Details

Caroline Gibson
Datchworth, Hertfordshire, UK

Email: cgibson@omniaquae.com

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