Jack Garvey is a practicing attorney, consultant, former industry professional and business owner, and is the Founder and Managing Attorney of The Garvey Law Firm.

Jack has focused his professional career and legal practice in the area of Food and Drug law and regulation. Jack possesses years of practical, business-focused experience as an attorney, working in both legal and non-legal roles, within and for both large and small companies. Jack not only understands legal and regulatory theory, but is intimately familiar with the hands-on issues facing FDA-regulated companies everyday, along with how to address risk with pragmatic actions and approaches to achieve positive, value-based, client outcomes. This is Jack’s true differentiation: his ability to provide clients with solutions that are grounded in comprehensive technical fundamentals, and that meet or exceed statutory and regulatory requirements and corresponding expectations.

<strong>Credentials</strong><strong>Legal Experience</strong><strong>In-House Company Experience</strong><strong>Career Accomplishments</strong>
EDUCATION

Bachelor of Science, Chemical Engineering, Clarkson University, 1984

Juris Doctor, Pace University School of Law, 1991

BAR ADMISSIONS

State and Federal Courts of New Jersey, 1991

State of New York, 1992

Northern District of New York, 1992

Devorsetz, Stinziano, Gilberti & Smith, Syracuse, NY

Thorn & Gershon, Albany, NY

C. R. Bard, Murray Hill, NJ

The Garvey Law Firm, Robbinsville, NJ

Ayerst Laboratories, Inc., Rouses Point, NY

Ciba-Geigy Corporation, Suffern, NY

C.R.Bard, Inc., Murray Hill, NJ

BASF Corporation, Mount Olive, NJ

Johnson & Johnson, New Brunswick, NJ

Accenture/BMS Operations, Princeton, NJ

Halo Pharmaceuticals, Whippany, NJ

Successfully directed and managed all planning activities of a global, cross-functional, cross-divisional supply-chain re-engineering initiative, resulting in proposed operating capital savings in excess of $50 million

Nominated to and participated on Congressional Suspicious Orders Task Force. Improved BASF’s reputation with Federal and State law enforcement agencies; reduced BASF’s regulatory risk; and negotiated the elimination of import quotas on over $200 million in DEA regulated product

Successfully directed management of and responses to multiple FDA inspections and 483s for drug dosage forms, APIs and excipients with no resulting Warning Letters issued

Provided complete regulatory leadership and market entry strategy for SAM-e, a new dietary ingredient which generated 1st year retail sales revenues in excess of $200 million

Regulatory clearance of Resultz Lice and Egg Elimination Kit as a medical device

Successful appeal against FDA for improper withdrawal of 510k prior to substantive review

Directed compliance consulting activities and drafted key policies and procedures for a $70 million medical device manufacturer, resulting in a successful FDA certification audit within 3 months

Counsel for in support of J&J’s SAFE (Secure Access for Everyone) initiative, delivering legal counsel on key technology initiative and framework for future electronic transactions

Jack is also the founder and Chief Executive Officer of Compliance Architects LLC (compliancearchitects.com). Compliance Architects® provides practical implementation expertise and capabilities to assist companies with resolving FDA regulatory and enforcement challenges and works with pharmaceutical, medical device, dietary supplement and other FDA-regulated companies.

Other practice areas of focus include complex commercial agreements, contract negotiation and drafting, small business and corporate counseling, and helping companies with the legal and regulatory issues surrounding product commercialization in a regulated setting.

Practical • Experienced • Helpful • Passionate

These are the terms that best describe Jack’s approach to the practice of law, regulation and business. If this sounds like the help you need to resolve your company’s current challenges, to reach Jack, please send him an email, or call him at: 609-277-3735.