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.
Cell and Gene Therapy Manufacturing
HiTech Health are delighted to have an article entitled 'Cell and Gene Therapy Manufacturing Considerations for Early Stage Companies' published in distinguished publications, cellandgene.com and outsourcedpharma.com. The article should be of benefit to companies who...
2024 ATMP Review
Over the past decade, the regenerative medicine landscape has undergone an extraordinary evolution with the continuous growth of Advanced Therapeutic Medicinal Products (ATMPs). ATMPs are medicines for human use that are based on genes, tissues or cells. They treat...
Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy
IDA Ireland, the agency responsible for the attraction and retention of inward foreign direct investment (FDI) into Ireland, has recently published an article entitled ‘Why Ireland is a proving ground for medicinal breakthroughs like cell and gene therapy’. Hitech...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
Contact us
Get in touch anytime – we are always available to discuss your upcoming projects.