Raleigh Molecular is a leader in the development and manufacture of intricate cGMP Active Pharmaceutical Ingredients (APIs). Our proficient scientists and recently updated cGMP development and manufacturing facility support the Drug Discovery process through API Synthesis for all stages of pre-clinical and clinical trials, as well as small-scale commercial manufacturing. We conduct cGMP manufacturing of APIs ranging from grams to multi-kilos. Our R&D and cGMP manufacturing areas can accommodate reactor sizes up to 300L. Custom Synthesis of Small Molecules and biopolymers is carried out in our state-of-the-art cGMP API manufacturing facility. Our two clean API suites are rated at Class C.
We are actively engaged in small-scale cGMP contract manufacturing of active pharmaceutical ingredients across various drug classes. A significant portion of the APIs we manufacture originated as Contract Research Projects or Custom Chemical Synthesis Projects with us. Our integrated services enable customers to seamlessly progress their API products from inception through to cGMP manufacturing, all within one company. Raleigh Molecular brings over 30 years of chemistry expertise to all API synthesis projects and ensures cGMP compliance through our stringent quality systems.
At Raleigh Molecular, Quality and Compliance are paramount considerations for us. We place special emphasis on equipment qualification and process validation and offer comprehensive regulatory support for our cGMP API manufacturing clients. Adhering to the strictest guidelines, conducting rigorous testing, and executing studies promptly are integral parts of our approach to ensure that your product maintains the highest quality standards upon reaching its destination.
Raleigh Molecular offers comprehensive services to develop, create, and execute validation protocols and studies necessary for your products and equipment, aligning with current Guidelines such as those from the U.S. FDA, Health Canada (HPFBI), EMA, ICH, and WHO, in acceptable formats such as prospective, retrospective, and concurrent.
Our validation services cover a wide range including process validation, cleaning validation, aseptic processing, terminal sterilization, environmental control, IQ/OQ/PQ/PV, and utility qualifications. We also provide statistical analysis and decision-making analysis as part of our service offerings.
We can expedite your Drug Development Program by consolidating process development, cGMP API Manufacturing, and finished dose manufacturing all under one roof at a single location.
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