ABOUT
Lessem Regulatory Consulting Group, LLC (LRCG) is a Boston based consulting firm specializing in Regulatory consulting for the Pharma and BioTech industry.
Martin A. Lessem, J.D.
Founder
Principal Consultant
Martin Lessem has worked in the Regulatory field for 15 years, and has served at all levels, up through Head of Regulatory Affairs, and has experience with multiple Health Authorities. He has directly, and successfully, interacted with the FDA, Health Canada, EMA, and TGA, in addition to various country level interactions in Europe and Latin America.
Diane Bloomer, MPH, RAC, MRSC
Senior CMC Consultant
Diane Bloomer is a Regulatory expert with more than 18 years industry experience including extensive CMC, International and Biologics experience. Created and established relationships with US Department of Defense (DOD), US Food and Drug Administration (FDA), US Department of Commerce (DOC) and International agencies including PEI (Germany) and DCGI (India).
Shirlene Davis
Senior Regulatory Consultant
Shirlene Davis is an 18 year Regulatory expert, skilled in the areas of Research and Development, Therapeutics, Oncology, Regulatory and Quality Operations regarding cGXP, (cGCP, cGLP, cGMP), cGDP, ICH regulatory standards, Biopharmaceuticals, Biotechnology Drug Development Process and Manufacturing, Clinical Trial processes, (Phases I - IV), and more.
Lisa Hunt
Build & Release Engineer
Lisa Hunt
Build & Release Engineer
Lisa Hunt has worked as a Build & Release Engineer for 14 years, and has served at various levels, including team leadership. She has experience with a wide variety of programming languages, and their application within various settings, including Pharmaceutical Device.
PARTNERS
Siza Mphele
Managing Director
Clinical Research Mgr.
Independent CRO operating across Africa
• Access to Patients and great Patient Retention Rate
• Access to a wider Investigator Database
• Affiliated to a larger Network of sites
• Adequate Trial Management Infrastructure
• Supply Chain Management Expertise
Services & Support
• Study Feasibility
• Site & Investigator Selection
• Investigator Management
• Site Monitoring
• Data Cleaning /Analysis
• Regulatory Agency Communication
Freyr is a leading global Regulatory consulting services and solutions provider with an exclusive focus on entire Regulatory
value-chain of Global Life Sciences industry. Freyr, with a deeper understanding of regional/local Regulatory requirements
of 120+ countries, caters specialized Regulatory services to over 60+ clients across the globe availing support from rapidly
growing 400+ Regulatory experts virtually situated in the US, UK, Germany and India.
Some of Freyr's Services & Support
• Regulatory Affairs, Operations, & Strategy
• Regulatory Intelligence Services
• Regulatory Outsourcing
• Regulatory Labeling & Artwork
• Regulatory Information Management