Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and ...
This article reviews the international requirements for the registration of pharmaceuticals, focusing on the information needed to define the pharmaceutical quality of drug substances and drug products. It highlights the role of NMR spectroscopy in regulatory dossiers that support applications to market ...
Regulatory Framework in Pharmaceutical IndustryPharmaceutical IndustryRegulatory FrameworkThis paper deals with the various kinds of regulatory bodies present in the pharmaceutical industry and also covers the aspects of environmental, intellectual property rights & taxation laws which govern the pharmaceutical ...
)The pharmaceutical industry is subject to strict regulatory controls to ensure the safety and effectiveness of drugs.(制药行业受到严格的监管控制,以确保药物的安全性和有效性。)The government has tightened regulatory scrutiny of financial markets to prevent another economic crisis.(政府已经加强了对金融...
The key focus areas include: (a) addressing misconduct in key areas of the pharmaceutical industry, such as corruption issues in the sales and procurement of pharmaceutical products, bribery cases involving pharmaceutical representa...
Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD...
当当中华商务进口图书旗舰店在线销售正版《海外直订医药图书Regulatory Affairs in the Pharmaceutical Industry 制药工业的监管事务》。最新《海外直订医药图书Regulatory Affairs in the Pharmaceutical Industry 制药工业的监管事务》简介、书评、试读、价格、图片等相关
aThe pharmaceutical industry is experiencing a time of unprecedented challenge. Patent expiries, regulatory issues and increased pressures from healthcare providers have combined to create an environment where our sector is associated with lower growth and higher risk 工业制药体验史无前例的挑战的时期。
Discover how our commitment to exceeding quality standards can help you meet regulatory requirements in the pharmaceutical and nutraceutical markets.
Drugs authorized in the EU go through a strict Linguistic Review process. Understand the process and why translation quality is vital for approval. READ MORE Lionbridge’s Pharmaceutical Translation Services Thought Leadership We understand your industry’s complexities and regulations. More from our expe...