EU and UK Qualified Person (QP) Services
Our Qualified Persons (QPs) can offer expert quality support to your company to successfully release your product to clinical trials or to market in the EU, UK and RoW
HiTech Health is a leading provider of Qualified Person (QP) services in the EU and UK. Our QP team have extensive knowledge of pharmaceuticals, biologics and Advanced Therapeutic Medicinal Products (ATMPs) including cell and gene therapies. We can help with all quality and compliance activities from your overall quality management system through quality audits and QMS remediation support. Our comprehensive services include:
- QP certification of imported product into the EU and UK markets under HiTech Health’s Manufacturer’s / Importater’s Authorisations (MIAs).
- Clinical QP batch release services in accordance with Clinical Trial Regulation 536/2014 and European GMP Guide
- Commercial QP batch release services in accordance with EU GMP Annex 16.
- Audits performed by our QP team.
- Remediation of quality issues identified during regulatory inspections.
- Tailored QP guidance on your clinical or commercial products.
By partnering with HiTech Health and working with our QP team, we can import and QP release batches in both the EU and UK markets.
- Fixed price on an annual basis
- Fixed term projects
- Daily rates for Quality assurance (QA) and Qualified Person (QP) support