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We meet all applicable local, state and federal regulatory requirements, including current GMPs and GLPs and country guidelines for the U.S., Canada, EU and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), chemical and pharmaceutical wastes (EPA), child-resistant container-closures (CPSC) and employee safety (OSHA).
2320 Scientific Park Drive
Wilmington, NC 28405 US