Project Management
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.
EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)
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 Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA
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 Appoint Clare O’Sullivan as Global Head of Commercial
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...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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