HiTech Health provides end-to-end project management solutions, supporting your products throughout the lifecycle while safeguarding the high quality and compliance.
An extension of your internal team
- Overall project planning and management of products.
- Oversight of planning, preparation, and submission of the application dossier (E.g. IMPD, IND, CTA, NDA, MAA) with all required competent authorities.
- Dedicated project management resource that will act as an extension to your internal team and work closely with your providers of raw materials, drug substance, drug product, analytical testing to ensure they are aligned.
Project Plans and Tracking
- Helping you to map your product launch. You can rely on us to track and monitor key development and manufacturing activities through regulatory filing and launch.
- How effective is the communication with your key partners? HiTech Health is highly experienced in working to ensure your suppliers meet your project goals and timelines.
Working closely with your internal team, HiTech Health can assist with ensuring key milestones are met by using advanced project management tools. Find out more in software solution.
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...
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...
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