Providing the data to support the science, from early formulation to release and stability testing
Serán maintains two well-equipped analytical facilities: a formulation development laboratory, and a GMP Quality Control laboratory.
In our formulation development lab, we deploy a variety of techniques to assess the physical properties of drug substances and prototype formulations. Careful collection and evaluation of the right data enables rational scientific choices leading to optimized formulations, even in Phase 1.
Our QC lab ensures that raw materials used in GMP manufacturing, as well as intermediates and dosage forms manufactured at Serán, meet applicable quality standards. The QC lab also performs chemical and physical stability assessments of drug substance and drug product. Our lab also has the capability to develop new analytical methods for your compound. All methods are validated to ensure consistent and expected performance.
Your drug is your future, but the path to a successful product is daunting. You need a CMC partner that’s as committed to your success as you are. Seràn offers a comprehensive set of drug-development services that begins with a detailed understanding of your project and goals. We deploy a science-based methodology that rapidly identifies a preferred approach that will enable an efficient advancement of your drug to the clinic and beyond. Our science, quality systems, regulatory expertise, and customer service are second to none.
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