We provide advice related to the various licenses required for manufacturing, sales and distribution under the Pharmaceuticals and Medical Devices Act, advice related to the acquisition of product approval and transfer thereof, data exclusivity issues, pricing, delisting of products from the market and NHI Price List, requirements for GMP, GCP, GPHC adverse event reporting, recall and other regulatory matters.

Representative Experience

  • Advised a global pharmaceutical manufacturer on Japanese regulatory issues related to labeling and assay requirements.
  • Advised a multinational life sciences company on its regulatory strategy for companion diagnostics and resulting life cycle management matters.
  • Assisted a biotechnology company in the identification of its most effective regulatory pathway and in the clearance of regulatory hurdles to the introduction of its innovative technology in the US, Europe, and Asia-Pacific region.