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About QIS

Management | Who We Are | How Do We Become an Extension of Your Team

Quality Implementation Services, Inc. (QIS), a leading FDA Consultancy firm, empowers Life Science companies with sustainable knowledge, cutting-edge tools and resources to interpret ever-changing complex regulatory requirements to easily assimilate compliance into science and technology which ultimately drives a product to market.

Our FDA consulting company offers exceptional services in developing, stream-lining and implementing compliance and quality system programs for all sizes of companies. We have expansive capabilities to serve cGLP, cGMP, and QSR environments in pharmaceutical, medical device, biotech, and dietary supplement industries.   Services include quality assurance activities, analytical laboratory controls, validation and process controls, and training. 

We provide highly qualified experts that take a practical approach to problem-solving aimed at reducing risk and increasing product viability at any stage of the product commercialization process. QIS is comprised of veteran experts from industry, former FDA and accomplished scientists. Our seasoned FDA consultants have prepared comprehensive responses to FDA’s regulatory actions such as FD-483’s and Warning Letters, and critical compliance scenarios such as consent decrees.  QIS’s extensive experience with PAI readiness initiatives has resulted in hundreds of successful inspection outcomes.

Our team of regulatory experts provides strategy and tactical support to assist with regulatory submissions to meet current eCTD specifications for drugs and 510(k) filings for medical devices. We also offer IND, NDA, ANDA and pre-submission technical review support for FDA-regulated industries around the globe.

Our mission is to build strong and lasting alliances with our clients by extension of support services to improve compliance, diminish risk and assist with realization of critical business goals. We’re dedicated to your success and focus on providing innovative and customized solutions to every unique challenge.
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