Lessem Regulatory Consulting Group, LLC (LRCG) is a Boston based consulting firm specializing in Regulatory consulting for the Pharma and BioTech industry. LRCG brings 15 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.