About Us

Kimberly K. Egan founded Saltbox Consulting in 2012 to provide strategic legal and compliance counseling for entities regulated by FDA and USDA. She is committed to providing the highest level of practice at a fraction of the cost of large law firms.

Education

Duke University School of Law, JD 1997
Columbia University, Barnard College, BA 1992
Harvard Business School — DLA Piper Executive Education Program 2011

Bar Admissions

State of New York
State of Maryland
District of Columbia
United States District Court for the District of Maryland
United States District Court for the District of Columbia
United States District Court for the Southern District of New York
United States District Court for the Eastern District of New York
United States Court of Appeals for the District of Columbia Circuit

Experience

Saltbox Consulting, Maryland — 2012 to present.
- Founder. Strategic, legal and compliance counseling and enforcement matters for entities regulated by FDA and USDA. Focus includes GxP compliance for drug, device, cosmetic and food companies and litigation support for FDA-related mass torts and product liability cases.
- Focus includes GxP compliance for drug, device, cosmetic and food companies and litigation support for FDA-related mass torts and product liability cases. Current clients include drug, medical device and diagnostics manufacturers, private equity life sciences and health care funds, cosmetics manufacturers, food and beverage manufacturers and retailers, and dietary supplement manufacturers.

DLA Piper LLP (US), Washington, D.C. — 2005-2012
- Partner. Co-Chair of U.S. Health Care Sector, Chair of Life Sciences Sector’s Clinical Trials Working Group. First Chair of the firm’s U.S. Healthcare Sector. Grew the group from a handful of practitioners scattered over various practice groups to over 100 lawyers across the firm working together as a single team. The practice was named to Legal 500’s list of leading health care practices in the second year of its existence.
- Substantive practice included: (i) full service FDA counseling and strategic regulatory advice for food, device, cosmetic, and pharmaceutical companies as well as private equity and venture capital firms, academic institutions, consulting firms, and health care providers, and (ii) complex commercial litigation for pharmaceutical and other clients focusing on regulatory fact and expert witness development and defense.
- Notable recent engagements include Celebrex and Bextra (2006-2008) and Chantix (2008-2012) product liability defense for Pfizer; multi-million dollar Good Clinical Practices internal investigation for Wyeth; full service regulatory support for a large telecommunications company’s medical device products in the U.S., Brazil, Australia, and various European markets; litigation and regulatory support for all global clinical trial claims against a multi-national pharmaceutical company; full service regulatory support for an international consulting company’s health care and life sciences offerings in the U.S. and numerous other global markets; Good Manufacturing Practices internal investigation for Pfizer subsidiary; regulatory and legislative support for private label dietary supplement and food matters for two national pharmacy chains; regulatory support for dietary supplement matters for a retail pharmacy; and full service FDA support for diagnostics, traditional medical devices, and OTC and prescription drug companies.
- Editor of DLA Piper’s Health Care Law Matters blog and guest contributor on food issues for quality assurance blog hosted by Assurx.

Covington & Burling, Washington, D.C. — 1997-2005
- Associate. Complex commercial litigation, white collar investigation work, regulatory and legislative advice. Senior associate for pharmaceutical client being investigated by DOJ, Congress, and a consortium of State Attorneys General. Senior associate on various litigation matters, including commercial dispute before the London Court of International Arbitration, trade secret and business tort litigation for biotechnology client, and software-development trial for a client in the on-line research business. Conducted oral arguments before state courts, federal courts and federal administrative agencies; deposed senior corporate executives, CEOs and expert witnesses; prepared expert testimony, expert reports, trial evidence and witness examinations for civil actions in state and federal courts; prepared written testimony for administrative proceedings before the Surface Transportation Board; represented clients’ interest before Members of Congress and Congressional committees; prepared draft legislation.

Publications

Co-Author, Is It Time for Harmonized Cosmetics Standards? A Comparison of U.S. and E.U. Cosmetics Regulations, FDLI’S FOOD & DRUG POL’Y FORUM, Vol. 3, No. 2 (Dec. 11, 2013).
Co-Author, Regulations For Biosimilars: As Biologic Drug Patents Begin to Expire, Generic Versions Will Hit the Market, But How Will They Be Regulated?, THE SCIENTIST, June 2012
Co-Author, GETTING THE DEAL THROUGH: LIFE SCIENCES (US CHAPTER), February 2011
Author, What Associates Didn’t Learn in Law School, NATIONAL LAW JOURNAL, February 28, 2011
Co-Author, GETTING THE DEAL THROUGH: LIFE SCIENCES (US Chapter), Feb. 2010
Quoted in FDA’s New Enforcement Initiative for 2010, FINANCIER WORLDWIDE, Jan. 2010
Quoted in A Glimmer of Hope for Retrospective Analyses of Data, GOOD CLINICAL PRACTICE JOURNAL, June 2009
Author, Mitigating Corporate Corruption in the Healthcare Industry, FINANCIER WORLDWIDE, July 2009
Co-author, Made in China: Five Opportunities Created by the Recent Recalls, FOR THE DEFENSE, International Law section, March 2009
Author, Does FDA’s ‘Changes Being Effected’ Final Rule Really Change Anything?, Member Briefings, AMERICAN HEALTH LAWYERS ASSOCIATION, 2009
Co-author, The China Syndrome: Five Lessons to Learn from Recent Scandals Involving Chinese Products, RICHMONDMAGAZINEONLINE.COM. December/January 2009
Co-Author, Genetically Modified Foods Raise New Legal Issues, NATIONAL LAW JOURNAL, June 25, 2001

Presentations

Panelist, Best Practices for Compliance in Gray Areas, Food & Drug Law Institute’s Advertising & Promotion Conference, Washington, D.C. (Sept. 16, 2013).
Speaker, Track-and-Trace: Selected Regulatory Requirements, FDANews Biopharmaceuticals Good Distribution Practices Summit, Bethesda, Maryland (Mar. 20, 2013).
Speaker, Quality Agreements: Managing Contract Distributors, FDANews Biopharmaceuticals Good Distribution Practices Summit, Bethesda, Maryland (Mar. 19, 2013).
Panelist, CBI’s Clinical R&D Compliance Forum, Philadelphia (June 28-29, 2010).
Presenter, Supply Chain Challenges in the New Regulatory Environment, Association of Corporate Counsel, San Francisco Bay Area Chapter (April 27 and 29, 2010).
Presenter, Global Supply Chains Issues in the Global Era: Prevention, Protection and Compliance, Ass’n of Corporate Counsel, Baltimore Chapter, Baltimore, Maryland (Jan. 27, 2010).
Presenter, Trends and Developments in Consumer Product Enforcement and Litigation, Hong Kong Productivity Council & Federation of Hong Kong Industries, Hong Kong, China (Jan. 22, 2010).
Panelist, Global Supply Chains in the Global Era: Prevention, Protection and Compliance, Ass’n for Corporate Counsel Chicago Chapter, Chicago, Illinois (July 22, 2009).
Co-leader, The Impact on Emerging Growth Companies of Issues Affecting FDA Regulations and Compliance, Hot Topics in Regulatory Affairs Workshop, co-sponsored by DLA Piper and CONNECT, San Diego, CA (June 23, 2009).
Speaker, Shoring up Weak Links in the Pharmaceutical Supply Chain, Webinar, Marsh Risk Consulting & Pharm. Manufacturing (Oct. 28, 2008).
Presenter, DRI Webinar, Drug Development and Approval: A Partnership Between FDA and Industry – Crossing Paths with FDA (July 18, 2006). Panelist, D.C. Bar Association Lunch Program, Issues Facing Women Litigators, Summer 2002

Honors

Legal 500 Recommended Health Care and Life Sciences Lawyer (2011)
International Who’s Who of Life Sciences Lawyers (since 2009)
International Who’s Who of Business Lawyers (since 2009)