There is a tremenous amount of pharma related research data produced in Europe every year, a large portion of which ends up in the back of a dusty drawer after it has been published in a scientific journal. This is very unfortunate since research is expensive and the invested money will not result in a beneficial contribution to society.
There are several reasons for this phenomenon, a major one being the lack of knowledge on how to move a research “proof of concept” towards the preclinical or even the clinical stage. The different disciplines that are required and the applicable guidelines that need to be followed to develop a product with sufficient quality to obtain approval, make preclinical and clinical development complex and create serious hurdles for the initial inventor to move forward.
This is where Saudade Pharma can step in and provide support to inventors and starting organisations. With over 10 years of experience in early and late stage development of medicinal products, Saudade Pharma can offer the detailed expertise of pharmaceutical development as well as the helicopter view required to keep clear focus on the target when moving through the different development stages. Although Saudade Pharma has the most indept knowledge on the pharmaceutical and CMC parts, experience from managing project teams with RA, QA and clinical experts has resulted in sufficient knowledge of other disciplines to communicate at the required level.
Saudade Pharma consulting is a small and independent company specialized in pharmaceutical development and CMC (chemistry manufacturing and control) of medicinal products. It was founded bij Jan Wit, a chemical professional with experience in pharmaceutical development and project management.
After obtaining his PhD in Organic Chemistry, Jan worked as a chemical researcher for several years before moving into the pharmaceutical development of generic medication. More recently, Jan managed the full development of a nanomedicinal product from benchtop scale to a 40L scale GMP batch and accompanying release testing. This nanomedicine entered the clinical phase I in August 2015.