Providing MAH Services from a Pharmaceutical Company within CMIC

OrphanPacific is a pharmaceutical company within CMIC Group, which provides wealth of experience in the field of orphan drugs: regulatory affairs, supply chain management, quality assurance, pharmacovigilance and sales & marketing.

We collaborate with our partner companies in a flexible manner, providing you with coverage of the whole spectrum of pharmaceutical activities from development to promotion in Japan.

Our Edge in Orphan Drug

Considerable Experience in Orphan Drug Market in Japan

  • Supporting to obtain Orphan Drug Designations (ODD) and Approvals through filing/ listing drug prices, and subsequent sales plus Post Marketing Surveillance (PMS: All Case Surveillance is mandatory for orphan drugs in Japan)
  • Development and selling of ultra-orphan drugs, such as Buphenyl®, Normosang®, Somazon®, Lynspad®, Orladeyo® and Dantrium® (partially designated) as well as marketing and selling of essential drugs
  • Accumulated Know-How to reach the limited number of rare disease patients and healthcare professionals in an efficient manner

Flexible Business Model for Partnering

  • Collaboration with partner companies, such as both foreign and Japanese Mega pharmas, in a flexible manner tailored to their growth and strategy with our groups’ resources.

For the unique, specialized and flexible support OrphanPacific can provide, please click here for more information.

Services

  • Support for In-Country Clinical Caretaker (ICCC) duties
  • Regulatory Affairs
  • CMC, Technology Transfer and Release Testing
  • Manufacturing and Packaging/Labeling (CMO management)
  • Quality Assurance
  • Safety Management (Pharmacovigilance and Post-marketing Surveillance)
  • Medical Affairs
  • Marketing
  • Supply Chain Management
  • Sales and Distribution
  • Post-marketing Surveillance

To view products provided by Orphan Pacific, a subsidiary of CMIC Group, please click here

in-country clinical caretaker

In-Country Clinical Caretaker (ICCC)

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Regulatory Affairs

Tech Transfer

Technology Transfer

Drug Manufacturing

Development and Manufacturing

Quality-Assurance-RGB

Quality Assurance

medical device

Medical Affairs

Contract Sales Organization with Globe

Sales & Marketing

Post-marketing surveillance-RGB

Post-Marketing Surveillance

IPM Japan

Japan Market Entry

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