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.
New FDA ‘Super Office’ created for Cell and Gene Therapy Products
The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Importation of Medicinal Products: Understanding the EU requirements
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
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...
Telephone
IE: +353-1-9631489
UK: +44-20-30267419
US: +1-857-3265835
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