Qualified Person (QP), Quality & Supply Chain Services
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. We hold MIAs in both the EU (HPRA) and UK (MHRA).
Quality Assurance (QA) Support
Our highly experienced team can provide a diverse range of Quality Assurance (QA) services for your organisation. We can support with GMP compliance, GMP and GDP vendor audits, Quality Management System (QMS) implementaton and more.
Importer / Exporter of Record (IOR / EOR)
HiTech Health can act as an Importer of Record (IOR) and Exporter of Record (EOR) in the EU and UK, helping to ensure your medicinal products can reach patients on time.
Regulatory and Compliance
We work with our clients to provide regulatory and compliance support with particular focus on the EU (EMA), UK (MHRA) and USA (FDA) requirements. Our team can support you with CTA, MAA, IND, NDA, BLA and additonal regulatory filings.
Project and Supply Chain Management
We can provide comprehensive project and supply chain management services. Our expertise ranges from small molecule products through to complex cell and gene therapies.
Quality Management System (QMS)
We specialise in the generation, and implementation of robust Quality Management Systems (QMS) that ensure the highest level of quality and compliance.