Michael J. Gregor

Michael has done great work for me. He was diligent in completing our project and tracking action items. He brought an in depth knowledge of the Electronic Records / Electronic Signatures regulations as well as a reasonable approach to ensuring compliance. He collaborated very effectively with our many customer groups and balanced appropriate autonomy with knowing when to seek our guidance regarding our internal procedures and interpretations of regulations. Michael is one of the best consultants I have hired in 18+ years in the pharmaceutical industry.

Michael is a seasoned professional with world class experience. His knowledge of FDA compliance is vast and he is a detailed manager. I would highly recommend Michael for any position, but especially when the need for a skilled professional is the highest, and the timeline is critical, Michael is your guy.

Michael was hired by Astellas to assist and lead the integration of another organization for IT Compliance. Michael did a great job, he has deep subject matter expertise in the area of Computer Systems Validation and the associated IT Strategy. He is also very easy to work with and all key stakeholders that he worked with enjoyed working with him. I look forward to working with Michael in the future.

I have had the pleasure of working closely with Michael Gregor over the past eight months on a significant systems validation project. We turned to Compliance Gurus for consultation services during a validation project for one of our largest customers. Michael provides personal oversight of the project while his experienced staff supports us in meeting our key milestones every step of the way. Michael's experience and professionalism is exceptional. We have developed a strong partnership with Compliance Gurus that has been an important part of our expansion initiatives. I highly recommend Michael and Compliance Gurus for handling a wide array of compliance and regulatory initiatives.

Michael was brought on board by my company to fill a very specific need of my Life Sciences client — specifically assistance with the validation and disposition of 200+ systems from an acquisition. Michael quickly became an integral part of the team and a trusted adviser to the client. Michael's excellent work resulted in him being extended 4 times by the client. I would highly recommend Michael, and will keep him in mind for other Life Sciences clients I have in the future.

I worked alongside Michael for the past several months at Philips Healthcare. I found him to be very knowledgeable concerning FDA compliance and related issues. Michael worked independently and developed his own decisions from a quality, regulatory, and validation perspective. Michael has several years of industry experience as a consultant to many companies. He brought a significant breadth and depth of knowledge from those experiences into his consultancy at Philips. I would gladly work with Michael again, if the opportunity arose.

Michael is a true professional in the world of compliance, validation and quality. Not only is Michael extremely efficient, but is always approachable no matter how big or small the problem may seem. Over the years it has been amazing to see Michael incorporating web technology to enhance the flow of validation and compliance knowledge on a global scale. I very much look forward to collaborating with Michael in the future.

Michael and his firm Compliance Gurus were an instrumental third party involved in guiding various stakeholders through a validation of the processes and systems on the implementation of a Learning Solution and LMS within a regulated industry. Assisted by Michael's tireless efforts, knowledge of validation and FDA regulation, and organizational skills, we were able to realize that implementation. I'd gladly hire Michael as an FDA consultant, if a need for such skills arose in the future.

Michael has been a great resource for demystifying a subject of tremendous importance to our customers. His knowledge of the subject (FDA Compliance) and ability to explain in a manner what is required to meet obligations of these requirements has been invaluable. Michael's willingness to take a call anytime from customers is an indicator of his commitment to this subject.

Michael is the type of high energy talent that will bring a lot of value to an organization. Michael brings a tireless work ethic, and genuine enthusiasm for his work to any project that he is involved with. It was a pleasure working with Michael.

Michael ultimately delivered on the reason our family's manufacturing business had hired him: he helped us pass our Good Manufacturing Practices audit. He is reliable, honest and delivers results.