REGULATORY SUPPORT
Function
Effective regulatory support paves the way for approval from government and other authorities enabling production and commercialization of pharmaceutical drug products. The Aayushi Pharmaceuticals Regulatory Support team functions throughout development, manufacturing and distribution to assist with timely completion and submission of documentation, as well as to provide optimal pharmaceutical analytical services.
Compliance
Federal regulatory agencies continue to implement more strict compliance guidelines for pharmaceutical drug products. The maintenance of current compliance requirements and the implementation of new regulations are the responsibility of the Aayushi Pharmaceuticals Regulatory Support Department. Comprehensive knowledge of requirements is necessary to design quality systems to comply with regulations. Regulations in the packaging and labeling department are subject to rules established in the Drug Supply Chain Security Act (DSCSA). Aayushi Pharmaceuticals is compliant with current DSCSA regulations.
Drug Listing
Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture or process drugs in the U.S. to register with the FDA. Proper registration of pharmaceutical drug products makes it possible to improve public safety by monitoring usage, tracking potential product shortages and determining products that are marketed without prior approval.