Quality assurance

All of our pharmaceutical and clinical operations are controlled within a formal documented quality management system in accordance with all current directives, regulations and guidelines. We are routinely inspected by the MHRA for GCP and GMP. We are also regularly audited by sponsors, typically participating in over 50 audits per year.

Qualified Persons (QPs)

Our QPs form an integral part of the development team to ensure they have full understanding of the product, the process, associated documentation and real-time release, to support your clinical program. They provide:

  • GMP certification for drug products manufactured on-site;
  • QP declarations for importation;
  • and regulatory release for dosing.