Blue Bell Scientific Technology Consulting

Blue Bell Consulting, a premier contract research organization (CRO) headquartered in the U.S., launched ¡Training Courses on U.S. FDA Regulations¡ in 2005. Emphasized in exporting finished dosage forms to the U.S., these comprehensive and intensive training courses are aimed to fulfill significant unmet needs in China while helping biomedical, pha... rmaceutical and medical device companies, regulatory bodies, and academic institutions to understand U.S. FDA regulations. Topics of these courses range from, GMP, GLP, and GCP compliance, regulatory requirements of DMF, IND, ANDA, NDA, IDE, 510(k), PMA application to pharmacoeconomics and international market analysis. Also, FDA GMP training course series have been collaboratively developed by several renowned former U.S. FDA senior inspectors and instructed in the U.S., Europe, and Japan. ¡Medical Device cGMP: QSR Compliance¡ training course is developed by the U.S. FDA, which is used as internal training material for its reviewers and inspectors. Since the ¡BBC Training¡ was launched, our Open Training courses have been in high demand, receiving enormous interests and high opinions from pharmaceutical companies and regulatory authorities. In addition, Blue Bell Consulting has also collaborated with the SFDA Training Center many times to offer GMP training courses and frequently conduct on-site trainings at the invitation of pharmaceutical companies, medical device companies, dietary supplement companyies and Contract Research Organizations (CROs).Read More