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.
Good Distribution Practice (GDP): 3 Considerations for Ensuring Compliance
Ensuring product quality and integrity is maintained throughout the end-to-end supply chain of medicinal products is imperative. The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities...
HiTech Health presented at the 3rd Global Bioprocessing, Bioanalytical, and ATMP Manufacturing Congress in Dublin, Ireland
HiTech Health are delighted to have attended the 3rd Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress on 16th and 17th May. HiTech Health’s Quality and Compliance Lead Julie-Anne O'Neill and Manager of Cell and Gene Therapy Operations Aoife Duffy...
Understanding the New EU Clinical Trial Regulation (CTR)
On the 31st January 2022, The Clinical Trials Regulation ((Regulation (EU) No 536/2014)) became effective and replaced the previous Directive (EC) 2001/20/EC and corresponding national legislation. The Clinical Trials Regulation (CTR) coordinates the review and...
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