Our Consultants have had years of experience delivering various MS&T Project including but not limited to New Product Introduction and Technology Transfer.
New Product Introduction
Our team of experienced Consultants have had experience in delivering Complex and multifaceted New Product Introduction (NPI) projects. They generally require changes to production methods, equipment, analytical methods, lab equipment, environmental and health and safety systems. New products can be at different phases of development for example Validation, Registration Stability or Early Phase Development and this governs the requirements of the project i.e. Products that are being validated and setup for commercial manufacture will require long term solutions that are robust while products that are in development and require only small quantities need to be cost-effective and deliver flexible solutions that are phase appropriate. ICH 7, 8 and 9 requirements need to be met while also achieving the commercial success factors for the product.
A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred.
Technology transfer (TT) is defined as “the transfer of the manufacturing process for a new pharmaceutical Drug Substance (DS) and Drug Product (DP), respectively, from the transferring site (in this case R&D) to the receiving site or designated commercial manufacturing site.” This includes all the associated knowledge, information and skills to be able to manufacture the DS and DP at the receiving site.
Manufacturing Science and Technology (MS&T)