Our Global R&D Department is responsible for the industry-oriented Process Development of all new products, and has capability to support the industrialization of these products in the three continents.
Simultaneous chemical and analytical development, scale-up under cGMPs, and transfer and validation services, are provided. Core teams are set up for all incoming projects, from evaluation to validation. Business Development, IP and Regulatory are also involved during the entire development process.
“New Development Concepts”, such as PAR, QbD, DoE, process simulation, etc., are taken into account during development, with special attention paid to the solid form of the final API (particle size, polymorphism…).
Our R&D team also supports product validation and industrialization by preparing QRAs, HAZOPs, etc.
Since 2007 the R&D team has been involved in more than 10 NCE projects carried out through commercial manufacturing.