top of page
Unbalanced Scales of Justice

Robert Guzman Esq, LLM, PE

Attorney at Law

Email: rguzman@prologoslaw.com

Robert Guzman is a seasoned lawyer and licensed professional engineer with a rich background in AmLaw 200 firms, complemented by extensive expertise in business and science. With over 25 years of experience, he has excelled in leadership roles within small and global organizations, serving as a trusted advisor on a wide range of complex issues. Robert is proficient in mentoring staff and fostering a collaborative team environment that underscores responsible leadership and corporate growth. He integrates rigorous legal analysis, ethical considerations, and alignment with corporate financial objectives to drive strategic outcomes. His career includes on-site projects across more than 20 countries, and he has successfully navigated regulatory challenges in international trade, representing clients whose products are marketed in over 125 countries.

Attorney Profile

​EDUCATION:

  • Master of Laws (LLM), Commercial and Corporate Law – University of London, United Kingdom

  • Doctorate of Law (JD) – Pontifical Catholic University School of Law

  • Master of Chemical and Life Sciences (MCLFS) - University of Maryland-College Park

  • Master in Business Administration (MBA) - University of Massachusetts-Lowell

  • Bachelor of Sciences in Industrial Engineering (BSIE) – Polytechnic University

.

ADMISSIONS TO PRACTICE LAW (All Current):

  • District of Columbia (Washington D.C.)

  • United States Court of International Trade (USCIT)

  • State of New Jersey

  • US District Court of New Jersey

​​

OTHER LICENSES & CERTIFICATIONS (All Current):

  • Registered Professional Engineer P.E. (North Carolina, US)

  • US Healthcare Compliance Certification – Seton Hall University School of Law

  • EU Healthcare Compliance Certification – Seton Hall University School of Law

  • RAPS US Regulatory Affairs Certification (US RAC)

  • American Society for Quality Fellow (ASQ)

  • ASQ Certified Manager of Quality and Organizational Excellence 

  • ASQ Certified Six Sigma Black Belt (CSSBB)

  • ASQ Certified Quality Engineer (CQE)

  • ASQ Certified Reliability Engineer (CRE)

  • ASQ Certified Quality Auditor (CQA)
     

BOARDS & COMMITTEES:

  • Regulatory Affairs Professionals Society (RAPS) Jan 2009 / Apr 2013

    • Nominating Committee and Board of Editors

    • Regulatory Focus Magazine Board of Editors

  • Food and Drug Law Institute (FDLI) - Jan 2018 / Jan 2020

    • Medical Products Committee

  • Advanced Medical Technology Association (AdvaMed) – Jan 2022 / Jul 2024

    • International Policy Group

    • FDA Strategy Group

    • Global Supply Chain Group

    • Promotional Advertising Group

  • American Society for Quality (ASQ) – 1994 - Present

    • ASQ Fellow Group

    • Section 1500 Educational Chair (2000 – 2004)

    • Section 1113 Educational Chair 2006 – 2008)

​

SPEAKING ENGAGEMENTS:

  • Speaker, “Importing Medical Devices, FDA and US Customs Issues”. Annual FDA Enforcement Conference - Food and Drug Law Institute (FDLI) · Dec 2018.•

  • Speaker, “FDA PreMarket Tobacco Approval (PMTA) - Where to Start”. North Guide Solutions - Ontario, CA USA · Oct 2018.

  • Speaker, “Speaker, “How to Identify and Interpret Quality Science”. Food & Drug Law Institute (FDLI) at National Press Club Washington DC · Oct 2018.

  • Panelist, “Exploring the futuristic concept of a site-less trial to identify best practices for recruiting remotely and ensuring you remain compliant”. Outsourcing in Clinical Trials East Coast 2018 by Arena International, United Kingdom · May 2018.

  • Speaker, “Compliance in an Evolving International Landscape”. The 4th Annual Medical Device Strategic Sourcing - Q1 Productions · Apr 2018.

  • Speaker, “PreMarket Tobacco Approval (PMTA) Strategy, Development and Submission to FDA”. Next Generation Nicotine Delivery 2018 - Atlanta, GA USA · Apr 2018.

  • Speaker, "Practical Strategies for Structuring Supplier Service Agreements". International Contract Service Expo (ICSE) - Philadelphia, PA USA · May 2012.

  • Speaker, "Developing Robust CMO Contracts". IQPC - Philadelphia, PA USA · Dec 2011.

  • Speaker, “Auditing CMOs and Developing Effective Monitoring Processes”. International Quality & Productivity Center (IQPC) - Philadelphia, PA USA · Dec 2011.

  • Speaker, “Contract Development & Management to Reduce Risk & Ensure Quality”. Next Level Pharma - Brussels, Belgium · Nov 2010.

  • Speaker, "Quality Engineering Thinking Applied to Process Validation". ASQ at North Carolina State University - Raleigh NC USA · May 2010.

  • Speaker, "A Regulatory Approach for Contract Manufacturing". The 9th Contract Manufacturing for Pharmaceuticals and Biotech, IQPC - San Francisco, CA · May 2009.

​

ARTICLES & PUBLICATIONS

  • “Medical Device Marketing Under Substantial Equivalence - FDA Clearance and USPTO Patent Considerations”. Regulatory Affairs Professional Society (RAPS), 2018.

  • “Food and Drug Administration Enforcement”. US Fundamentals of Regulatory Affairs 13th Edition. Regulatory Affairs Professional Society (RAPS), 2017.

  • “A View to Strategic Partnering”. Pharmaceutical Outsourcing Magazine, 2017.

  • “Regulatory and Revenue? How Commercial and Regulatory Can Achieve Synergies”. HS&M Magazine, 2016.

  • “Regulatory Aspects of Contract Manufacturing”. Pharmaceutical Outsourcing Magazine, 2010.

Need more details?  We are here to assist. 
bottom of page