Regulatory Affairs Services in Vietnam
The Ministry of Health (MoH) is responsible for overseeing all regulatory activities for pharmaceutical products including medicines, biologicals, and medical devices. Under the MoH, the Drug Administration of Vietnam (DAV) acts as the vietnam drug regulatory authority for pharmaceuticals, while the Department of Medical Equipment and Construction (DMEC) monitors medical device activities. Additionally, the Department of Pharmaceutical Management (DPM) ensures compliance with WHO Good Manufacturing Practices (GMP), improving export potential by meeting internationally recognized standards.
To secure marketing authorization for a drug, manufacturers must obtain either a drug manufacturing or a drug trading license from the DAV. Only Vietnamese-based entities can apply, making it essential for foreign companies to collaborate with local DAV regulatory partners. Partnering with established regulatory affairs service providers greatly increases the likelihood of success when submitting dossiers.
Why Choose DDReg as a Regulatory Partner in Vietnam?
As a leading regulatory consulting services firm, DDReg offers comprehensive Regulatory Affairs Services in Vietnam. We provide ongoing support through every regulatory phase, adapting to the latest requirements to ensure high-quality, timely submissions. Our services include safety assurance, risk mitigation, and expert collaboration to streamline 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
- MA Holding Services
- Pharma Regulatory Labeling
Our Regulatory Affairs Consulting Services in Vietnam portfolio covers:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
