Regcellent Consulting LLC provides expert consulting services on compliance, regulatory affairs, and technical matters to domestic and international clients. Through a multidisciplinary team of industry, regulatory, and scientific professionals, Regcellent helps pharmaceutical firms to prevent and resolve compliance problems and to develop efficient and effective strategies for the submission and approval of pharmaceuticals applications. Regcellent adopts the services of only highly experienced consultants who consistently deliver top-quality results for a diverse base of domestic and international pharmaceutical clients.
The Trusted Experience and Professional Service
The primary Goal of any pharmaceutical company are the new products they have in development that have the promise of making a positive difference to patients and providing revenue for the company. Getting to the approval of these products will require diligence and focus in research efforts, patience with the reporting of data and the ability to work effectively and cooperatively with the agency regulatory personnel.
Regcellent Consulting LLC specializes in US Food and Drug Administration (USFDA) regulatory matters. Our prime focus is to assist domestic and foreign pharmaceutical firms comply with applicable laws and regulations. Regcellent is assisted by an extensive network of consultants with many years of FDA compliance and industry experience and strategically located throughout the USA. We offer comprehensive, technology-based consultation and management services that are custom-designed to solve your specific needs. Our thorough understanding of regulatory requirements, data management, and systems development means that we possess the necessary expertise to help you put systems in place that will meet the requirements of 21 CFR Part 11, 210 and 211 respectively. Our strict Quality Assurance and Validation processes approaches ensure that your systems will meet the requirements of an FDA audit.
Regcellent Expertise helped lot of companies in designing regulatory strategies that not only addressed the direct issues of FDA, but also focus on efforts that will balance cost, speed to market and the identification of the most promising regulatory approval process for the product. These strategies need to be well thought out, perfectly prepared and excellently presented in order to be maximized. Regcellent approach drives to create successful regulatory outcomes that benefit the client and society, on time and within budget. Today, Regcellent offers a robust suite of services for all facets of information capture, transformation, management and distribution, including large volumes of regulatory technical documents. And we do it all with a commitment to precision, quality and customer service. Regcellent Vision is to be recognized as leaders in Pharmaceutical Regulatory Services. Regcellent offers un-parallel regulatory services that will help you successfully process your regulatory submissions and faster approvals.