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Drug Regulatory Affairs

 Drug Regulatory Affairs refers to all aspects of the process of pharmaceutical development, and how they are subject to different levels of regulation. The pharmaceutical law system, guidelines covering consistency, protection and effectiveness as well as the perceptions and standards of the Health Authorities etc. have a significant impact on the process of drug production and its performance. Professionals in regulatory affairs deal with those aspects. The range of products covered is huge including food and agricultural products, veterinary products, surgical equipment and medical devices, diagnostic tools and tests in vitro and in vivo, and drugs (ranging from small molecules to proteins). A wide range of issues are addressed, such as manufacturing and analytical testing, preliminary safety and efficacy testing, clinical trials, and post-marketing follow-up. Advertising problems are thrown into the mix, including a good dose of data processing, paper planning , project management , budgeting, problem settlement, and dispute resolution. Regulatory agency in the gift context could also be described as "the competent authority responsible for ensuring that medicines work and are tolerably safe. The Pharmaceutical Regulatory Affairs Mission: Open Access Journal offers a forum for publishing new research on regulatory matters. Our primary research objective at the moment is to encourage and assist the development of better and faster measures of the Biochemistry & Pharmacology activities. In cases where we believe that we can contribute directly, rather than by highlighting the work of Biochemistry & Pharmacology. Their work is primarily of interest to investors, organisations and individuals in the financial sector and to large companies with global operations, as well as governments and academic researchers.  

High Impact List of Articles

Relevant Topics in Chemistry