DEVELOPING INNOVATIVE REGULATORY STRATEGIES
Providing Executive Level Strategic Regulatory Consulting for the Pharmaceutical Industry. Available for short or long term projects, both remotely and onsite, as required by your business needs.
Experienced Regulatory Guidance through the Drug Development process, from IND through Post-Marketing, including Orphan Designations, Expedited Pathways, and preparing for Agency Meetings.
Lessem Regulatory Consulting Group, LLC (LRCG) is headed by Martin A. Lessem, J.D.
LRCG brings 17 years of Regulatory and Pharmaceutical experience to bear in strategic solutions for the consumer. With work in all areas of the drug development process from the IND on through Post-Marketing, LRCG can guide you toward successful development of your product, through a robust Regulatory Strategy. This includes exploring expedited approval pathways, coordinating Health Authority interactions, review of documents, labeling strategy, Regulatory Risk Management, and helping to set-up a Regulatory Department where needed, including creating SOPs and procedures.
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.
LRCG believes in hands-on Regulatory Consulting. You will always get the best quality of Regulatory Strategy for your business, and we tailor our approach to your needs.