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.

PMTC Spotlight – HiTech Health

HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight.   HiTech Health is a full-service Contract Development and Manufacturing...

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