路透香港4月7日 - 中国开放式生物制药技术平台公司--药明生物周三称,已顺利完成美国食品药品监督管理局(FDA)针对其无锡生物药原液及制剂生产基地(MFG1,MFG2,DP1)展开的GMP检查。 公司称,这标志着公司符合国际标准的质量体系可以常态化接受全球药品 ...
The "GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries (Jan 28th - Jan 29th, 2026)" training has been added to ResearchAndMarkets.com's offering.This Auditing for GMP ...
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
The market opportunity lies in providing specialized GMP auditing courses to pharmaceutical professionals, enhancing their skills in compliance, evaluation, and reporting, thereby ensuring ...
The US FDA-Gujarat Food and Drug Control Administration (FDCA) Bilateral Regulatory Forum will be held in the month of January 2023 for the US and Indian drug regulators to discuss compliance to Good ...
The market opportunity lies in providing comprehensive training on GMP compliance for dietary supplements, highlighting FDA regulations, safety, and quality improvements. Bridging the knowledge gap ...