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Element blends regulatory acumen and an “always available” mindset to provide unmatched quality, compliance and customer service to support the expedient release of small and large molecule finished products in addition to the qualification of raw materials, APIs, excipients, intermediates, starting materials, cell banks, vectors, bulk harvest materials and control cells.

Testing and compliance to the standardized methods and specifications detailed within pharmacopeial compendia is a basic requirement for manufacturing release and distribution of biopharmaceutical ingredients and drug products around the world. Compendial methods may be implemented as part of routine quality control strategies, in addition to addressing anticipated regulatory concerns, and/or establishing general drug compatibility.

Element offers comprehensive compendial testing programs that meet specifications in the US Pharmacopoeia-National Formulary (USP/NF), European Pharmacopoeia (EP), British Pharmacopoeia (BP), the Japanese Pharmacopoeia (JP), and those that are set by the International Council on Harmonisation (ICH). Our compendia release testing solutions support a variety of drug products, including over the counter and generic drugs, pharmaceuticals, biologics and biosimilars, combination products, innovative and novel products and animal drug products. All compendial testing is performed per cGMP standards of 21 CFR 210 and CFR 211.

The Element advantage

Element offers a seamless partnership, providing full access to our consultative, technical team of CMC experts with extensive knowledge of regulatory requirements and years of experience testing a wide range of materials and drug products to USP compendial methods and FDA monographs. Bring safe and efficacious products to market expeditiously with a robust and effective quality control strategy that incorporates our comprehensive compendial and monograph testing services.

To learn about our compendial testing services for OTC drugs, generic drugs, pharmaceuticals, biologics, and biosimilars, or to speak with one of our experts, contact us today.