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.

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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