CimQuest-Vantage LLC (“CQV”) has become a recognized leader in providing a variety of compliance services to the Life Sciences Industry. As a full-service company we offer consulting services within the Quality Assurance, Laboratory, Clinical, IT/IM, Business Processes, Manufacturing, Operations and R&D settings.
A privately held, career based company incorporated in 1995, CQV, along with our Global Alliance partners, provides services worldwide and has successfully executed projects throughout the US, Canada, Puerto Rico, Switzerland, France, Ireland, the UK, Spain and Mexico.
Our knowledge of current regulatory expectations and international standards, combined with our technology expertise, enable us to understand the challenges and issues faced by pharmaceutical, biotech and medical device companies. We help our clients achieve their business goals and objectives while maintaining regulatory compliance and a state of control across all operational areas within the enterprise.
With a depth of expertise in all facets of the system life cycle we are able to assist our clients to reach their goal of Optimal Performance. This includes Research & Development, Clinical Trials, Quality Assurance, Laboratory, IT/IM, Operations, Manufacturing and Distribution. CimQuest will evaluate and access your current business operations then provide solutions to streamline processes and reduce regulatory exposure. The application and implementation of recommended standard solutions will increase harmonization and management of critical cross-functional business systems. Thus, mitigating the risk of non-compliance, reducing costs, increasing profitability, and helping to achieve Operational Excellence.
CQV has been working with regulated industries for decades, giving us a unique perspective and an understanding of what it takes for any size company to be in compliance with FDA and other governmental regulatory agencies. We have demonstrated expertise in the following areas:
· Mock FDA Inspections / Assessments
· RBA - Risk Based Approaches (Assessments, Validation and Management)
· Systems Selection, Configuration & Implementation Assistance
· IT / IM /Network Infrastructure / Servers / Component / Qualification
· Computer Systems Validation - CSV
· 21 CFR 11 - Electronic Records / Signatures
· Lab / Clinical / R&D / Manufacturing /
· Laboratory Commissioning / Lab Instrument Qualification
· Clinical Adverse Event Systems / Data Mgmt. and Safety / CAPA Systems
· Manufacturing Equipment Qualification and Process Systems (C&Q)
· Supplier Audits (Manufacturing, CRO, Software Supplier)
· Training / SOP’s
For more information Call 610.363.0422