Compendial专著 and Pharmacopeial 测试

im体育APP 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, api, 赋形剂, 中间体, 起始原料, 手机银行, 向量, bulk harvest materials and control cells.

测试 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.

im体育APP offers comprehensive compendial testing programs that meet specifications in the US Pharmacopoeia-National Formulary (USP/NF), 欧洲药典(EP), 英国药典(BP), 日本药典(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 仿制药, 药品, 生物制剂和生物仿制药, 组合产品, innovative and novel products and animal drug products. All compendial testing is performed per cGMP standards of 21 CFR 210 and CFR 211.

im体育APP优势

im体育APP 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, 仿制药, 药品, 生物制剂, 和生物仿制药, or to speak with one of our experts, im体育APP 今天.