Regulatory & Compliance
HiTech Health’s experienced and diverse team can support you to meet all your regulatory and compliance requirements, from strategy and planning to dossier writing and submission.
Regulatory Support
HiTech Health can support you in developing a regulatory strategy to ensure key milestones are met on the pathway to clinical and commercial realisation. We can also provide detailed regulatory input, support clinical trial applications, and assist with eCTD filings.
Compliance and Audits
HiTech Health has extensive quality and compliance experience and expertise. We can help with auditing suppliers, preparing for PAIs as well as problem solving where quality gaps are found.
Afortiori Development and HiTech Health Forge an Important Collaboration
Afortiori Development and HiTech Health Forge an Important Collaboration to Support the Clinical Research and Product Development of Groundbreaking Cell and Gene Therapies. Galway, November 9, 2023 - Afortiori Development, a premier full-service Clinical Research...
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of...
HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
Hitech Health's Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate's Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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