We focus our work on optimizing and stream-lining the systems already in place—not necessarily on replacing them. Our approach is to provide viable alternatives to reaching your milestones.
We utilize our broad capabilities, extensive skills, and knowledge to minimize time and cost to reach your FDA milestones. We develop customized solutions with clearly defined deliverables and value-added milestones.
We have a thorough understanding of the FDA regulatory process and how to deliver effective strategies, valuable advice and apply real-life experience to successfully commercialize FDA-regulated products.
We lend our solid work ethic to each project element and address every unique challenge with commitment, dedication and hard work to provide timely compliant solutions, documents and advice.
We have 25 years experience in the industry with over 50 clients and keep current on FDA expectations, industry trends and federal initiatives. .
Embracing the challenge to implement regulatory solutions is more than interpreting the regulations and applying a technology to a problem. QIS delivers reliable and sustainable Quality Management Systems that help you meet critical business and regulatory priorities, achieve tangible results, create competitive advantage and realize a return on your investment within realistic time frames.