Quality Assurance & Compliance

We strive for excellence in everything we deliver

Our QA&C team aspires to excellence and ensures that our teams perform to the highest standards. This experience is leveraged in our QA&C service offerings. We help customers conduct 3rd party audits and develop or update their quality systems and procedures.

Pivotal’s QA&C team is assembled by professionals with extensive clinical research experience and knowledge of the GCP guidelines and regulations. Our team is well- versed in 21 CFR Part 11 requirements and utilize an agile methodology for software development and validation.

Our quality assurance services

System audits (SOPs, processes and staff training)
Clinical site audits
Trial master file audits
Protocol and ICF audits
Clinical study documents audits
Clinical database audits
Laboratory audits
Vendor audits
Support clients in the preparation for regulatory bodies inspections
GCP training services

Our Solutions for Biotechs

We offer end-to-end clinical development solutions tailored to your needs. Whether you’re preparing for first-in-human or managing a global Phase 3 trial, our agile team delivers expertise, insight, and hands-on support at every stage.

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