EU and UK 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. We can support you with oversight of EU or UK importation, manufacture, and distribution of medicinal products in a diverse range of dosage forms. Our comprehensive services include:
- Quality Management System (QMS) development, implementation and maintenance
- QP certification of imported product into the EU and UK markets under HiTech Health’s Manufacturer’s / Importation 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
- Quality assurance audits
- Remediation of quality issues identified during regulatory insepctions.
- Designing and implementing robust supplier qualification and management processes
By partnering with HiTech Health and working with our cross-functional team, you can ensure a robust and effective quality system is in place enabling your company to provide high quality products to patients when needed We offer flexible pricing models to fit your business needs:
- Fixed price on an annual basis
- Fixed term projects
- Daily rates for Quality assurance (QA) and Qualified Person (QP) support