Click on the following image to see a November 2009 letter from a very satisfied CEO!

As founder of Compliance Architects^®, Jack Garvey has a demonstrated track record of exceptional performance for leading companies. Here are a few comments about Jack's approach to driving successful outcomes in and for leading FDA-regulated companies:

From a client:

Under difficult situations, with minimal resources and high demand level, Jack was able to successfully ensure compliance operations were performed to a high degree of competency. Further, Jack had responsibility to expand the compliance program framework, and successfully partnered with myself and my quality team to continually expand compliance operations beyond initial delivery. Jack represented [redacted] well, and provided exceptional leadership for the compliance program. Jack was a demonstrated leader, and was respected by his peers, subordinates and superiors.

November 2008

From an internal client:

Jack, just wanted to take a few minutes and thank you for supporting the QA & Regulatory Compliance initiatives at [redacted].  I also appreciate your participation on the [redacted] steering committee meetings and the Quality Notifications project. I believe you are able to balance the emotions of our collective organization with the reality of our regulatory environment.   I appreciate your perspectives and the support you provide to these initiatives.

October 2003

From a client:

I can attest to Jack's professionalism, leadership and subject matter expertise on this assignment. As with all audits and assessments, sensitivity to the organization being evaluated is paramount; however, it is important that a thorough evaluation of the operation is conducted. Jack balanced these difficult requirements extremely well. As a result of Jack's assistance, [redacted] received a thorough, timely and helpful analysis of our quality and compliance operation, resulting in [redacted] becoming better prepared for new business opportunities and preparing us for our first successful FDA inspection.

November 2008

From a client:

As a result of Jack's assistance [redacted] received a thorough, timely and helpful analysis of the target company's quality and compliance operation, resulting in a more complete analysis of the business case for the acquisition.

September 2008

From a colleague:

At [redacted], I was able to observe how Jack approached his work, his clients and his colleagues. Jack was a leader in the firm, and embraced ambiguity and difficult situations head-on. Shortly after entry to the firm, Jack was given responsibility for a complex, time-critical, multi-client assignment requiring exceptional project leadership and subject matter expertise. Jack embraced the assignment and delivered a substantial amount of unplanned revenue to the firm. Jack is well-liked by his colleagues, and is a pleasure to work with. Overall, Jack was an extremely valued member of the management team of [redacted], and would be an asset to any life-sciences organization struggling with business challenges and complex issues relating to FDA regulatory, compliance, quality, operations and law. I would recommend Jack highly.

November 2008

From an internal client:

Dear [redacted],

I would like to thank you for allowing Jack ... to perform the Quality Assessment of our facility. It was an extremely valuable exercise that gave us a better understand [sic] about the FDA expectations and our gaps to achieve full compliance. Jack and [redacted] were such nice partners, conducting the assessment with professionalism and energy but also, dedicating time to teach and explain the rational [sic] behind each observation.   In summary, it was a critical tool to help us prepare our plant for future regulatory inspections.

Thank you so much for the support and partnership.

October 2004

From an internal client:

Jack ...

The three days spent in [redacted] conducting our Mock FDA Inspection were outstanding.  The service you provided clearly exceeded our expectations!  It was a great opportunity to try out our new [redacted] site director, our new CAPA system and our new organizational structure in an FDA inspection that didn't count. It was gratifying to see the nearly 50 [redacted] staff members attend the Friday afternoon debrief! There was much interest and all agree it was a successful (and busy) three days. Thank you very much.

June 2004

From an internal client:

Jack,

The entire [redacted] Global Supplier Performance Management team thanks you for your support on 3/2/04 in [redacted].  Your 4 hour compliance training was exactly what the group was looking for and generated good enthusiastic discussion in the team during your stay that extended into the next day. We appreciate the time and energy you spent helping our team become functional in 2004 as a new organization.  The session will have direct impact to the effectiveness of supplier quality agreements.  Your comments that Compliance based audits are not the single most effective way to maximize business value through suppliers did not go unnoted[sic].  On Thursday, the team brainstormed on this topic. The output will be used to pull together a cohesive strategy for the team to leverage in 2004.

Thank you again!