We’ll work with you to develop a customized plan to help you realize your product’s value.
We have global experience across all phases in therapeutic areas with a client base that ranges from small start-ups to global, multinational companies. We also have experience in Good Practice (AKA GxP, this includes Good Clinical Practice – GCP, Good Laboratory Practice – GLP, Good Manufacturing Practice – GMP and Good Clinical Laboratory Practice – GCLP) disciplines across all phases and in many therapeutic areas.
We provide a flexible, fast and focused quality assurance service, either as a full-service commitment or on a project-by-project basis.
From aiding early detection of potential problems, to ensuring compliance with regulatory requirements, we provide a pragmatic, risk-based approach to audit. We are always pro-active and forward thinking, helping you to identify areas for improvement.
Our portfolio of audits and services include:
- Trial Master File
- Investigator Sites
- Contract Research Organisations (CROs) / Vendors / Investigational Medical Product (IMP) Depots
- Phase I Facilities
- In-life procedures
- Documentation including Protocols, Informed Consent Forms, Investigator Brochures, Clinical Study
- Reports and Marketing Authorization Applications
- GAP Analysis
- Document preparation and review
- Quality Management System (QMS) development and implementation
- Inspection readiness and mock regulatory inspections
We also offer a unique Site-Quality Control service to ensure you are inspection ready. Find out more about this service here.
Get in touch to find out more about quality assurance.