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.
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.
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'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...
Hitech Health is delighted to announce the appointment of Clare O’Sullivan as Global Head of Commercial. Brian Harrison, Managing Director of HiTech Health, commented on Clare’s appointment: “I am pleased to announce the appointment of Clare O’Sullivan as Global Head...
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