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Regulatory Services in Japan

Regulatory Compliance Experts in Japan

The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory body that works alongside Ministry of Health, Labour, and Welfare. The PMDA aims to protect the public’s health by guaranteeing the safety, effectiveness, and quality of pharmaceuticals and medical devices by assessing product safety, developing detailed regulations, and closely monitoring post-market safety surveillance. The PMDA also provides compensation to those who suffer adverse drug or biological product reactions or infections. The three-pillar system that is unique to Japan covers crucial activities pertaining to medicinal product review, post-marketing safety measures, and relief services for adverse health effects. The PMDA has recognized the importance of global collaboration and have formed strong relationships with the EU, US, Asian and other countries to contribute towards important and relevant activities of the International Council for Harmonization (ICH), and for providing important drug safety information to the public as efficiently as possible.

As a leading global contender, DDReg’s Regulatory Services in Japan provide ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In Japan Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regultory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • API/DMF
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
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Call us on:+1 (302) 601-2755
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