We manufacture and distribute fine chemicals and laboratory
products - with quality and delivery you can count on every time.
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| 40 Years of Custom Synthesis Experience | ||||||||
Spectrum has more than 40 years of custom synthesis experience as a chemistry outsourcing partner to the pharmaceutical and biotechnology industries. We provide a full range of contract research and manufacturing services, including the custom synthesis of new chemical entities (NCE’s) through commercial cGMP manufacture of active pharmaceutical ingredients (API’s), DEA Controlled Substances (Schedules I-V) and their chemical intermediates. Our highly qualified staff of Ph.D. chemists will follow your project in our facilities from discovery through commercialization, providing an unparalleled level of service throughout the R&D, scale-up and manufacturing process. • Custom Synthesis of NCE’s Spectrum Custom Synthesis offers our customers a unique experience, combining the personalized service and responsiveness of a mid-size company with the resources, logistics, and technical depth of much larger companies. |
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| Research and Production Facilities | ||||||||
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| cGMP Quality Systems and Regulatory Compliance | ||||||||
Spectrum Custom Synthesis has in place the documentation, validation, and qualification systems to ensure compliance with the FDA, DEA, ICH, WHO and other worldwide regulatory entities. Our expertly trained Quality Assurance and Regulatory Affairs team works closely with our customers to navigate the regulatory maze associated with compliance to worldwide cGMP standards, securing quotas for controlled substances, regulatory filings, and audits. Spectrum Custom Synthesis fiercely protects the confidentiality and security of Intellectual Property (IP) and Technology Transfer Agreements, whether provided by our customer or developed by our Scientists. • FDA Registered and Inspected Facilities
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| Core Synthetic Technologies | ||||||||
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