Rosam Legal & Consulting Group, LLC

Overview

Rosam Legal & Consulting Group, LLC has over 30 years of experience in the regulatory Drugs, Medical Device & Biologics fields. Retford Berko is an experienced FDA Attorney with expertise in medical devices, drugs, biologics and combination products. He is a registered Patent Attorney with emphasis in biochemical, chemical and pharmaceutical arts. He has significant International Experience From both FDA's Office of Compliance and FDA's Office of Device Evaluation: J.D. ,University of Missouri, Kansas City, School of Law, (May, 2002)

· Relevant experience-Legal research and writing capabilities combined with experience in biomedical sciences for cost-benefit analysis of regulatory decisions in approval of medical devices, biologics and drugs. · Ph.D. Biochemistry, University of North Carolina, Chapel Hill, NC (August, 1979) · Relevant Experience gained from thesis work- designing research protocols, conducting research in animal models, evaluating scientific data and writing the results for publication in scholarly journals. · Certification in Leadership Development and Project Management, Johns Hopkins University, School of Business, Baltimore, MD (May, 1994) · My management experiences applicable to Industry include: · Graduate Certification in Leadership and management from Johns Hopkins University, Baltimore, Maryland (May, 1994). · Management with 9 Reportables-Associate Biochemist and Laboratory Manager, Clinical Chemistry and Toxicology Laboratory (Jul 81 - Dec 84). · Management with 6 Reportables as Director for Scientific Projects and Contracts Manager, Louisiana State Board of Regents for Higher Education Baton Rouge, LA (Apr 87 - Aug 88).

Standards & Methodologies

Rosam Legal & Consulting Group, LLC has not posted any Methodologies at this time.

Qualifications, Certifications, Accreditations & Licenses

*ISO 13485 *21CFR, Part 820, *EU law *510K *IDE *BLA & PMA applications to FDA *FDA dossiers for medical devices, biologics, & drug applications for submissions to FDA *draft warning letters *CE MTG Requirements *CGmp Regulations *EIR Inspection Reports *CAPA & Form 483 violation determinations respecting *Part 820 Quality System *Provide FDA Expert Advice on Intellectual Property