Quality Assurance

We’ll work with you to develop a customized plan to help you realize your product’s value.

The expertise

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.

The structure

We provide a flexible, fast and focused quality assurance service, either as a full-service commitment or on a project-by-project basis.

The service

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
  • System/Process
  • Database
  • Pharmacovigilance
  • 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.

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