APIs and manufacturing processes
R&D Ofichem focuses on the development of new products and processes. We are a professional and flexible organisation with R&D chemists, analysts and process technologists who are committed to offering and carrying out the entire development process as effectively and efficiently as possible. Service and unburdening are important cornerstones in our development projects. Because of the short lines of communication with the Lab Ofichem GMP production facility, we can make a flawless translation from R&D lab scale to commercial GMP production. Our analytical experts are ready to develop and validate the right set of analytical methods for each product so that the final product can be released for use by our QA and Regulatory Affairs (RA) department.
STRONG IN BOTH COMPLEX R&D PROJECTS AND COMMERCIAL GMP PRODUCTION.
Total solution
R&D Ofichem offers the total solution, from API synthesis and process development to commercial GMP production. We offer synthesis development/route scouting, analytical development, scale-up of production processes and extensive validation together with analytical solutions aimed at the identification of degradation products or impurities.
From our own Contract Research Organisation (CRO) team and/or in close cooperation with Ofipharma, Ofichem and Ofidit, we search for the most reliable, high-quality and cost-efficient starting materials.
From the start of each project, we work according to GMP by design, which ensures a carefree translation of the R&D results into our state-of-the-art GMP production facility, where our R&D specialists oversee upscaling, pilot production and process validation in close cooperation with Lab Ofichem.
We offer development pathways for 'Clinical Research Phases 1, 2, 3’ to commercial production and have a range of manufacturing workshops from small-scale production (20l) to multi-MT production (up to 1800l per batch).
We use a flexible approach, communicate transparently and are known for our short timelines. We are distinguished by our independence and extensive experience in both complex R&D projects and structured and controlled GMP production. Our internal organisation, with its in-house Quality Assurance and Regulatory Affairs department, ensures that we work in accordance with the most recent ICH Q7 guidelines, and our extensive experience with ASMF/DMF submissions nationally and internationally completes our service.
