Catapult Life Science has the facilities and will establish equipment for chemical synthesis on a scale up to 50 liters in a chemical process lab. Furthermore, the center will be able to make dry powder, using freeze-drying, and spray-drying and -granulation from the onset. Moreover, we will assist our clients with guidance in product development, both for drugs and medical devices.
It is important to integrate quality in the product development process from the beginning. It is crucial for an effective product development to meet existing requirements including quality standards and regulatory guidelines, to do everything “good enough” in the early stages.
The goal is to minimize costs without compromising standards. In order to manage expectations and adapt to the demands in the early stages of drug development, thorough knowledge of the requirements that apply in the various phases of product development, including the requirements of different markets and the differences/similarities between pharmaceuticals, medical devices or other, is essential.
In conjunction with our network Life Science Pilot, we will assist our clients with expertise in all phases of product development and we can mediate the dialogue with Legemiddelverket. We will provide instructions as to how a product can meet its requirements and articulate the necessary documentation for the product.