Scaling up new drugs and medical technologies can present a number of challenges. HiTech Health’s cross-functional expertise and dynamic team of consultants assist with all aspects of the scale-up process. We believe it is critical to deeply embed knowledge at the new receiving site from the donor site and this is often overlooked leading to product launch delays.
HiTech Health can project manage the scale-up and transfer of new and existing products, both to internal and external sites.
We will work with you to select the right suppliers to address your needs, based on the product and business requirements.
For products currently in R&D, we support process development and scale-up through to New Drug Application (NDA)/ Marketing Authorisation Application (MAA) filing.
Our in-house experts can assist you navigate from small scale clinical supply to full commercial production. We place a strong emphasis on ensuring product supply is robust, high quality and cost effective.