With 40+ years of experience and new investment in expanded R&D facilities, Grace's Fine Chemical Manufacturing Services (FCMS) team is a leading CDMO who will collaborate on the development of your cGMP pharmaceutical or nutraceutical project. From the lab to the pilot plant, and all the way through commercial production, we have the technical skills and experience to achieve your goals with optimized speed, efficiency and meeting all compliance requirements.
Easy access to know-how
Not only has Grace's FCMS successfully developed hundreds of APIs over many decades, including a portfolio of proprietary generic APIs that we supply today, but we are one of the few in the industry to have consistently integrated development of RSMs domestically with scale-up all the way to commercial API manufacture in U.S. facilities. The R&D support, accessibility of this know-how, and capability are the fundamental differences between Grace’s FCMS and other outsourcing options.
In 2019, Grace's FCMS completed a 9,000 sq. ft capacity expansion of our R&D facilities, creating vastly more space for our teams to work on our customer’s projects at lab scale and kilo lab. Our experience and state-of-the-art facilities and equipment will progress your drug substance faster and more efficiently than ever before, providing solutions to development challenges.
Tightly integrated teams
Grace's FCMS R&D and analytical teams at South Haven, Michigan, Tyrone, Pennsylvania and Albany, Oregon are able to work together easily and bring diverse collective knowledge across regulatory starting materials (RSMs), intermediates and active pharmaceutical ingredients (APIs).
Development, testing, and validation
At our two facilities, we perform analytical development, stability studies and on-site validation. Our custom R&D group comprises chemists, engineers and analytical professionals dedicated to the advancement of your project.
Robust testing and validation
We can work with your technology or use our extensive resources in chemistry and chemical engineering to develop, test and validate efficient new processes. We subsequently thoroughly test these processes to optimize development time and costs. These are strengths that we are particularly proud of.
Analytics services and equipment