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Regulatory Services in Malaysia

Regulatory Compliance Experts in Malaysia

The Ministry of Health (MoH) of Malaysia is responsible for governing and protection of public health and the healthcare system. Many agencies of the MoH work together to ensure close regulation of medicinal products and patient safety. The National Pharmaceutical Regulatory Agency (NPRA) is responsible for ensuring the quality aspects of the products are in line with the regulations in place

The Drug Control Authority (DCA) monitors and evaluates the safety, quality, and efficacy of regulated products including registration and licensing. The Malaysian Adverse Drug Reaction Advisory Committee (MADRAC) of the DCA is responsible for drug safety and pharmacovigilance services for the regulated products, where all reported Adverse Drug Reactions after being assessed are communicated to the WHO Global ICSR database. The synergistic collaboration of these agencies ensures products that are safe, efficacious, and of high quality, are made available to the public in a timely manner. The requirements for biologics, combination drugs and medical devices are different to those of drugs.

As a leading global contender, DDReg’s regulatory services in Malaysia provides on-going support and development of the 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 Malaysia Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • 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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