Regulatory Services in USA

A robust regulatory system is important to ensure the safety, efficacy, and quality from pre-marketing to post-marketing phases of a medicinal product. The U.S. FDA is the governing regulatory authority in the USA for medicines, medical devices, biosimilars, vaccines, food supplements, Pharmacovigilance solutions, cosmetics, and more. The Center for Drug Evaluation and Research (CDER) issues different requirements for new drugs, generic drugs, and OTC drugs including New Drug applications (NDAs) and Abbreviated New Drug Applications (ANDAs). For new biologics a Biologics Licenses Application (BLA) is necessary for premarket approval. Thus, the U.S. FDA sets strict guidelines that manufacturers must follow to obtain compliant market authorization for their products depending on their category, which are also adopted by many other countries worldwide. However, due to the stringency of the guidelines and the ever-changing regulations many foreign manufacturers are unable to obtain compliant market authorization for their products.

As a leading global contender, DDReg’s Regulatory Services in USA provides on-going support and development of the customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations. For the U.S. market, we provide comprehensive services for NDA and ANDA applications as per sections 505 (b)(2) and 505(j) respectively. In-house or monograph specifications, protocols, reports, and completed ANDA or NDA dossiers (modules 1, 2, 3, and 5) are thoroughly reviewed as per the U.S. FDA requirements. All queries are responded to and include adequacy review for submission. All post-approval or minor changes are conducted including annual reports filing and prior approval supplement. We provide assistance for all ANDA requests made by the U.S. FDA.