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.
HiTech Health Authorised by the MHRA to Perform Batch Importation and Certification of Investigational Medicinal Products (IMPs)
HiTech Health today announced that the company has been granted a Manufacturer’s/Importation Authorisation (MIA) for Investigational Medicinal Products (IMP) by the Medicines and Healthcare Products Regulatory Agency (MHRA). The company is now authorised to perform...
Cell Therapy: Points to Consider When Choosing a CDMO
At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With...
Accelerating Regenerative Medicine : CCRM Australia and HiTech Health Announce Strategic Partnership
Hitech Health is delighted to announce its latest partnership with CCRM Australia, a not-for-profit organisation supporting regenerative medicine commercialisation in the Australian market. CCRM Australia works to accelerate the commercialisation of regenerative...
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.