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Regulatory Services in Vietnam

Regulatory Compliance Experts in Vietnam

The Ministry of Health (MoH) is responsible for overseeing all regulatory activities for pharmaceutical products including medicines, biologicals, and medical devices. The divisions that fall under the MoH includes the Drug Administration of Vietnam (DAV) that oversees pharmaceuticals, and the Department of Medical Equipment and Construction (DMEC) which monitors medical devices activities. The Department of Pharmaceutical Management (DPM) is responsible for ensuring that Good Manufacturing Practices (GMP) are implemented and adhered to the WHO’s GMP standards. This increases pharmaceutical product export opportunities as most countries accept globally renowned GMP standards.

In order to obtain marketing authorization for a drug, pharmaceutical manufacturers must obtain either a drug manufacturing or drug trading license from the DAV. However, only Vietnamese-based entities can obtain a license. Foreign companies that wish to seek marketing authorization for their products in Vietnam are more likely to succeed by partnering with an entity that has experience in the Vietnamese pharmaceutical regulatory sector.

As a leading global contender, DDReg’s regulatory services in Vietnam 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 Vietnam Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory 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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