Lachman Consultants’ Regulatory Affairs group is comprised of former senior-level FDA managers, FDA reviewers, and industry experts. Their goal is simple; provide simple, workable solutions for client’s regulatory problems or issues at the highest levels of efficiency and excellence.
Services and features include advising on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs, as well as prepare and/or provide assistance in the preparation and electronic submission of all types of FDA regulatory documents, including drug applications, e.g., ANDAs, NDAs (5050(b)(2) and 505 (b)(1)), DMFs (Type II, III, IV), and other FDA regulatory forms.SCHEDULE A CONSULTATION SUPPORTING AREA SERVICES MEET Regulatory Affairs LEADERSHIP
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Organizations around the world trust the people and services of Lachman Consultants to responsively guide and connect them with the best insights, information, and analysis to overcome their challenges and achieve optimum results.
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