Lachman Consultants brings both experience and excellence to its Biologics Consultation Services. Our comprehensive teams are selected and assigned based on each client’s unique set of objectives, needs, and circumstances.
Lachman Consultants offers a wide range of consulting services for areas that include medical products, SaMD, materials and components, processes and mechanical engineering and manufacturing, as well as testing and validation.
Lachman Consultants brings broad expertise and regulatory experience into the development and review of drugs under 505(b)(1), 505(b)(2), 505(j) and OTC pathways as well as 351(a) (biologics) and 351(j) (biosimilars), 510k and PMAs.
Lachman Consultants offers a full portfolio of capabilities to deliver measurable results for clients as they prevent and resolve compliance problems and develop new products for regulatory submission and approval by the FDA.