Start-to-End Clinical Trial Solutions in Vietnam
Accelerating an Attractive Destination for Clinical Trials & Drug Development
Vietnam is rapidly emerging as one of Asia’s growing pharmaceutical and clinical research hubs, driven by its diverse patient population, expanding healthcare infrastructure, cost-effective operations, and evolving regulatory environment. With the country advancing toward AI-driven healthcare, innovation, and global regulatory alignment, sponsors require trusted partners to navigate this dynamic landscape efficiently.
Zenovel offers end-to-end clinical research, GxP, and regulatory support services tailored to Vietnam’s evolving pharmaceutical ecosystem. Our experts are ready to assist sponsors with compliant, technology-driven, and high-quality solutions to accelerate drug development and market success in Vietnam.
Good Clinical Practice (GCP) Services in Vietnam for Clinical Trial
We Ensure GCP Excellence for Compliant Clinical Trials Across Vietnam
Clinical trials in Vietnam are regulated by the Ministry of Health, particularly through the Drug Administration of Vietnam and the Department of Science, Technology, and Training, which adhere to ICH-GCP guidelines. The recent Circular No. 50/2025/TT-BYT, effective February 27, 2026, introduces updated GCP principles and clinical trial procedures. Ensuring compliance with GCP is crucial for trial success.
Zenovel provides GCP compliance services in Vietnam to help sponsors, CROs, and biotech firms navigate these regulations.
Our GCP Compliance Services in Vietnam Include:
- Audit Support, Quality System Evaluation & Inspection Readiness
- Risk‑Based Compliance Assessments & Deviation Management
- Site Oversight, Vendor Compliance & CAPA Implementation
- Audit Trail Reviews & Documentation Control
At Zenovel, our team collaborates with clinical and quality teams to create sustainable compliance frameworks that prioritize practical execution and inspection readiness, leveraging global regulatory experience to reduce compliance uncertainty and adhere to local expectations.
We are recognized as a trusted GCP compliance partner for clinical trials in Vietnam.
Computer System Validation (CSV) Services in Vietnam for GxP Compliance
In Vietnam’s clinical and pharmaceutical sectors, digital systems for trials and manufacturing must meet reliability, security, and compliance standards. The Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) prioritize data integrity and system validation, following ICH guidelines.
Here, Zenovel provides Computer System Validation (CSV) services to ensure GxP systems align with MOH/DAV expectations and international standards, including WHO and 21 CFR Part 11 principles, while promoting operational efficiency.
Our CSV Services in Vietnam Include:
- Validation planning, risk assessment & IQ/OQ/PQ execution
- Lifecycle documentation for EDC, CTMS, LIMS, eTMF, and ERP platforms
- Data integrity, system controls & electronic record compliance
- Audit‑ready, scalable validation aligned with your quality strategy
At Zenovel, we validate systems to ensure audit readiness, scalability, and alignment with local regulations and global quality standards. By collaborating with IT, QA, and clinical teams, we enhance compliance and operational performance, reducing validation delays and improving inspection readiness for audits by MOH, DAV, and international bodies, ensuring decisions based on digital systems are founded on validated compliance.
GCP Audit Services in Vietnam for Clinical Trial Compliance & Quality Assurance
Clinical trials in Vietnam, regulated by the Ministry of Health, Drug Administration, and Department of Science (Circular No. 50/2025/TT-BYT), are enhancing GCP compliance expectations.
Zenovel provides comprehensive GCP audit services to help identify and address compliance gaps before regulatory evaluations. Our GCP Audit Services in Vietnam Include:
- Site audits, sponsor audits, vendor audits & system-level quality reviews
- Alignment with ICH E6(R3) guidelines, MOH/DAV regulations, and WHO standards
- Assessment of protocol adherence, informed consent processes, documentation accuracy & data integrity
- CAPA development, risk‑based quality improvement & inspection readiness planning
At Zenovel, we specialize in identifying and resolving compliance gaps in clinical operations, ensuring organizations remain audit-ready. With expertise in clinical quality assurance and GCP compliance in Vietnam, we help mitigate regulatory risks, enhance operational discipline, and strengthen sponsor confidence, making us a trusted GCP audit partner for organizations focused on inspection success and trial integrity.
CRO Setup & Upgradation Services for GCP Compliance in Vietnam
Empowering CROs for Vietnam’s Clinical Future from Framework to Full Compliance
Enhancing a CRO in Vietnam requires compliance with the Ministry of Health (MOH) and Drug Administration of Vietnam (DAV) regulations, particularly Circular No. 50/2025/TT-BYT, which adopts ICH E6(R3) GCP standards effective February 27, 2026. With Vietnam’s emergence as a clinical trial destination, adhering to updated GCP principles, such as risk-based quality management, is crucial for success. Zenovel offers comprehensive support for achieving GCP compliance and operational excellence in new or existing CROs.
Our CRO Setup & Upgradation Services for GCP Compliance in Vietnam Include:
- Operational framework design & quality management system (QMS) setup
- SOP development aligned with MOH/DAV, Circular No. 50/2025/TT-BYT, ICH E6(R3), and WHO GCP standards
- Risk‑based monitoring (RBM) integration & vendor management frameworks
- Inspection readiness planning & mock MOH/DAV GCP audit support
- Scalable, audit‑ready clinical trial infrastructure
Zenovel collaborates with clinical, QA, and regulatory teams to develop compliance systems aligned with MOH/DAV standards and global benchmarks, ensuring that CROs are prepared for inspections and focused on performance from study start-up to close-out.
PK‑Stat Review Services in Vietnam for Seamless Clinical Data Analysis
We Offer Reliable PK-Stat Solutions for High-Quality Clinical Research in Vietnam
In clinical development, minor errors in pharmacokinetic interpretation can significantly affect dosing decisions and regulatory outcomes. Zenovel’s PK-Stat review services in Vietnam offer precise pharmacokinetic analysis in accordance with the Ministry of Health, the Drug Administration of Vietnam, and international ICH guidelines, ensuring compliance with both local and global regulatory standards.
- Non‑compartmental analysis (NCA) & population PK modeling
- PK/PD evaluation aligned with MOH/DAV and global expectations
- Clinical biostatistics and data review for accuracy and validation
- CDISC compliance (SDTM/ADaM) & submission‑ready outputs
At Zenovel, our expert team interprets data with a scientific and regulatory focus, collaborating with clinical pharmacology and biostatistics teams to ensure data integrity, reduce variability, and enhance decision-making in clinical trials. It serves as a reliable PK-Stat and biostatistics partner in Vietnam.
Pre‑Inspection Readiness Services in Vietnam for GCP Compliance
We Assist You in Preparing Your Studies for Confident GCP Inspections in Vietnam
Zenovel provides pre-inspection readiness services in Vietnam aimed at ensuring compliance with GCP standards and regulations set by the Ministry of Health, the Drug Administration of Vietnam, and Circular No. 50/2025/TT-BYT. Our set of services assists sponsors, CROs, and sites in identifying and addressing compliance risks ahead of regulatory inspections.
Our Pre-Inspection Readiness Services in Vietnam Include:
- Comprehensive gap assessments & mock regulatory inspections (MOH/DAV style)
- Documentation reviews & quality system evaluations
- Assessment of informed consent, protocol adherence, data integrity & vendor oversight
- CAPA effectiveness review & inspection response strategy
At Zenovel, we collaborate with your clinical and quality teams to enhance QMS processes, strengthen audit trails, and prepare for regulatory scrutiny, ensuring readiness for MOH, DAV, or international inspections. As a readiness partner in Vietnam, we prioritize inspection success for a seamless regulatory transition.
Consult us today to have a smooth transition of regulatory inspection.
Risk‑Based Monitoring (RBM) Services in Vietnam for Efficient Clinical Trials
We Help Transform Clinical Monitoring with Data‑Driven RBM in Vietnam
Risk-Based Monitoring (RBM) services in Vietnam are crucial to optimize clinical oversight, addressing the shortcomings of traditional monitoring methods that can delay trials and overlook critical risks. At Zenovel, we offer RBM services across Vietnam that prioritize patient safety and data quality while adhering to the guidelines of the Ministry of Health (MOH), Drug Administration of Vietnam (DAV), and ICH E6(R3).
- Centralized monitoring & key risk indicator (KRI) development
- Site risk assessment & real‑time data review strategies
- Alignment with MOH/DAV expectations and ICH E6(R3) guidelines
- Transition from routine on‑site to data‑driven, risk‑proportionate monitoring
At Zenovel, we get together with clinical operations and data management teams to develop risk-based monitoring plans that enhance issue detection and trial efficiency in multi-site studies. This strategy enables early risk identification, optimal resource allocation, and improved regulatory compliance, positioning Zenovel as a strategic partner for efficient and compliant clinical trials in Vietnam.
We plan to improve your clinical trial with our RBM procedure.
Sponsor Oversight Services in Vietnam for Clinical Trial Governance
We Strengthen Clinical Trial Governance with Trusted Sponsor Oversight in Vietnam
To enhance visibility, control, and accountability for sponsors managing complex clinical trials, the need for sponsor oversight services is vital in Vietnam. To comply with the governance expectations of the Ministry of Health, the Drug Administration of Vietnam, and Circular No. 50/2025/TT-BYT, Zenovel is offering sponsor oversight services in Vietnam:
Our Sponsor Oversight Services in Vietnam Include:
- CRO performance oversight & vendor management
- Quality monitoring & risk‑based governance frameworks
- KPI tracking, responsibility mapping & consistent execution oversight
- Alignment with ICH E6(R3) guidelines and MOH/DAV expectations
At Zenovel, we enhance quality systems, communication, and risk management in clinical trials in Vietnam, serving as a reliable oversight partner with expertise in governance, accountability, and inspection readiness.
Good Manufacturing Practice (GMP) Services in Vietnam for Pharma Compliance
We Empower Pharma Manufacturers with GMP Integrity in Vietnam
In Vietnam, pharmaceutical manufacturing is subject to strict regulations from the Ministry of Health and the Drug Administration, adhering to standards like ASEAN GMP and WHO GMP. Zenovel provides GMP services to help pharma and biotech companies ensure compliance and improve operational reliability.
- GMP audits, quality system (QMS) design & review
- Deviation management, CAPA implementation & documentation control
- Alignment with MOH/DAV, ASEAN GMP, WHO GMP, and global standards
- Inspection readiness support & risk‑based compliance frameworks
Zenovel partners with quality and manufacturing teams to improve compliance systems, reduce risks, and maintain consistency, focusing on practical, risk-based strategies that prioritize actual regulatory outcomes instead of merely theoretical compliance.
We serve as your trusted GMP partner in Vietnam for reliable manufacturing and inspection‑ready operations.
GMP Audit Services in Vietnam for Manufacturing Quality Assurance
Advancing Manufacturing Standards with GMP Expertise in Vietnam
Pharmaceutical manufacturing in Vietnam is regulated by the Ministry of Health and the Drug Administration, where quality lapses can lead to severe consequences like import bans or license revocation. Zenovel provides GMP audit services in Vietnam to ensure compliance with MOH/DAV regulations, ASEAN GMP, WHO GMP, and international standards through expert assessments of manufacturing quality assurance.
- Production processes & quality management systems (QMS)
- Documentation control, batch records & CAPA effectiveness
- Vendor quality systems & root cause analysis of compliance risks
- Alignment with current MOH Circulars and ASEAN GMP requirements
Zenovel regards audits as opportunities for regulatory intelligence instead of simple checklist tasks. By utilizing experienced experts in pharmaceutical quality assurance and regulatory inspections, Zenovel enhances your manufacturing environment for optimal readiness during MOH/DAV or WHO inspections. For audit confidence supported by expert validation, we serve as your GMP quality assurance partner in Vietnam.
Pharma Plant Setup & Upgradation Services in Vietnam
Upgrading Pharmaceutical Facilities to Global GMP Standards
Establishing or upgrading a pharmaceutical manufacturing facility in Vietnam is regulated by the Ministry of Health and the Drug Administration of Vietnam, adhering to ASEAN GMP, WHO GMP, and national GMP standards. Zenovel provides services for creating compliant, scalable, and inspection-ready manufacturing environments, covering the entire process of GMP-compliant pharma facility setup in Vietnam.
- Plant design review, cleanroom classification & HVAC validation
- Equipment qualification (IQ/OQ/PQ) & QMS integration
- For existing facilities: modernization, gap closure, contamination control & process optimization
- Alignment with MOH/DAV, ASEAN GMP, WHO GMP, and global standards
At Zenovel, we combine engineering expertise and regulatory knowledge to improve operational efficiency and compliance while preparing facilities for audits. We work with manufacturing, QA, and validation teams to reduce regulatory risks and accelerate processes. Contact us to partner in building or transforming a GMP-compliant manufacturing site in Vietnam.
Preinspection readiness service for GMP compliance in Vietnam
We make sure your site is ready for future GMP regulatory inspection
Regulatory inspections are essential for pharmaceutical manufacturers, with inadequate preparation risking findings, production delays, or license suspensions. Zenovel offers expert pre-inspection readiness services for GMP compliance in Vietnam, ensuring operations meet the standards of the Ministry of Health, Drug Administration of Vietnam, ASEAN GMP, WHO GMP, and national GMP requirements.
Our preinspection readiness service includes:
- Gap analysis of quality systems, production processes & documentation
- Audit trail & CAPA system evaluation
- Mock MOH/DAV inspections & GMP audit preparation
- Continuous compliance improvement for Vietnamese and global regulatory alignment
We assist pharmaceutical companies, CDMOs, and sites in Vietnam in enhancing quality systems and reducing compliance risks to confidently handle MOH/DAV inspections.
Clinical & Scientific Expert Services in Vietnam for Drug Development
Offering Expert Clinical Insight for Every Development Phase in Vietnam
Early and late-stage drug development necessitates accurate scientific decision-making, backed by regulatory knowledge and clinical expertise. Zenovel provides clinical expert services in Vietnam to aid pharmaceutical and biotech companies in improving drug development strategies, optimizing study designs, and ensuring regulatory compliance with the MOH, the Drug Administration of Vietnam (DAV), and international ICH guidelines.
Our Clinical & Scientific Expert Services in Vietnam Include:
- Clinical development strategy & protocol design
- PK/PD interpretation & translational science support
- Biomarker strategy, endpoint selection & study design optimization
- Regulatory scientific consulting aligned with MOH/DAV and global guidelines
Zenovel collaborates with clinical, regulatory, and R&D teams to bridge preclinical research with clinical execution, offering science-driven drug development solutions that enhance efficiency and reduce uncertainty. We provide regulatory confidence in Vietnam and invite contact with our team for further engagement.
Medical & Scientific Writing Services in Vietnam for Regulatory Success
We Are Advancing Regulatory Approval Through Our Expert Medical Writing Services in Vietnam
Regulatory submissions in Vietnam require precise data and well-structured documentation to communicate effectively with authorities. Zenovel provides medical and scientific writing services, helping pharma, biotech, and CROs convert complex clinical data into submission-ready documents that comply with the Ministry of Health, the Drug Administration of Vietnam, and Circular No. 50/2025/TT-BYT, accelerating the approval process.
- Clinical study reports (CSR), protocols & investigator brochures (IB)
- Informed consent forms (ICF) & CTD/eCTD modules
- Pharmacovigilance documents & clinical summaries
- Full alignment with ICH guidelines and MOH/DAV regulatory standards
At Zenovel, we combine scientific expertise with regulatory accuracy to produce well-written, strategically structured documents that facilitate efficient reviews and successful approvals. Acting as an extension of regulatory and clinical teams, we enhance submission quality and alleviate documentation burdens, positioning ourselves as a reliable medical writing partner in Vietnam for expedited, inspection-ready regulatory reviews.
Preclinical Support Services in Vietnam for Early-Stage Drug Development
Preclinical support facilitates the smooth transition of innovative ideas into practical application
At Zenovel, we assist in enhancing your submission quality and alleviating documentation burdens, positioning ourselves to combine scientific expertise with regulatory accuracy to produce well-written, strategically structured documents that facilitate efficient reviews and successful approvals. Acting as an extension of regulatory and clinical teams, as a reliable medical writing partner in Vietnam for expedited, inspection-ready regulatory reviews.
Our Preclinical Support Services in Vietnam Include:
- In vitro & in vivo studies, toxicology assessment & PK/PD analysis
- Bioanalytical support & translational research
- Lead compound optimization, risk identification & safety evaluation
- Regulatory documentation aligned with MOH/DAV and global standards
Zenovel’s integrated CRO preclinical support services in Vietnam enhance study design, reduce delays and costs, and improve data accuracy, facilitating quicker transitions to clinical phases while ensuring compliance with MOH/DAV and international standards for small molecules, biologics, and complex therapies, positioning Zenovel as a trusted preclinical partner for clinical success.
Regulatory Affairs & Compliance Services in Vietnam for Global Submissions
We Accelerate Global Submissions Through Regulatory Excellence Across Vietnam
Navigating global regulations requires precision and expertise. Zenovel’s Regulatory Affairs & Compliance Services in Vietnam support pharmaceutical and biotech companies in product development and market authorization, ensuring smooth global submissions with the Ministry of Health (MOH), the Drug Administration of Vietnam (DAV), and international authorities like the FDA, EMA, and WHO.
- eCTD dossier preparation, IND/CTA submissions & NDA/BLA support
- Labeling compliance, gap analysis, and regulatory intelligence
- Lifecycle management & post‑approval maintenance
- Alignment with MOH/DAV, ICH, ASEAN, and global guidelines
We offer regulatory compliance services in Vietnam to help sponsors reduce submission delays and regulatory risks while ensuring compliance in product development. Our integrated approach enhances submission accuracy and facilitates faster global expansion, enabling quicker and compliant product approvals worldwide.
Dossier Due Diligence Services in Vietnam for Regulatory Accuracy
We Ensure Every Submission Meets Regulatory Expectations in Vietnam
A regulatory dossier may appear complete, but minor inconsistencies can lead to review delays by the Ministry of Health or the Drug Administration of Vietnam. Zenovel provides dossier due diligence services in Vietnam to ensure submissions meet both national and global regulatory standards, offering thorough CTD/eCTD dossier review services.
- Clinical data consistency & CMC documentation alignment
- Module integration & ICH guideline compliance
- Gap analysis for missing evidence, contradictions & formatting issues
- Submission risk assessment & quality assurance
- Alignment with MOH/DAV, ASEAN, and WHO requirements
Zenovel evaluates submission strategies by collaborating with regulatory, clinical, and CMC teams to improve clarity and coherence in documentation. This approach reduces submission risk, enhances quality assurance, and builds confidence during reviews by the Ministry of Health and the Drug Administration of Vietnam.
At Zenovel, our team guarantees that submissions are fully validated before reaching regulators in Vietnam.
eCTD Compilation Services for Global Regulatory Submissions in Vietnam
Offering you a Vietnam-Based eCTD Expertise for Worldwide Regulatory Success
Streamline your regulatory approval process in Vietnam with expert eCTD compilation services for pharmaceutical, biotech, and life sciences companies. Our services provide accurate and compliant electronic submissions that adhere to the Ministry of Health (MOH), the Drug Administration of Vietnam (DAV), and international standards, facilitating faster approvals and successful market entry.
- Document formatting, module‑wise structuring & quality validation
- Hyperlinking, publishing & submission readiness for MOH/DAV, ASEAN, and global authorities
- IND, NDA, ANDA, and BLA dossier management
- Full compliance with evolving eCTD, ICH, and ASEAN guidelines
Zenovel offers expertise in global regulatory submissions, focusing on minimizing errors, reducing review delays, and enhancing efficiency. This ensures data integrity and accelerates approval timelines for faster market entry, positioning Zenovel as a trusted partner for electronic submissions in Vietnam.
Environmental Risk Assessment Services for Regulatory Compliance in Vietnam
Delivering Compliance-Driven Environmental Risk Assessment Services in Vietnam
It is crucial to consider Environmental Risk Assessment Services in Vietnam to support pharmaceutical and biotech companies in meeting regulatory requirements and promoting sustainable drug development. With increased scrutiny from the Ministry of Health (MOH), the Drug Administration of Vietnam (DAV), and ASEAN guidelines, early assessments of active pharmaceutical ingredients (APIs) and formulations are crucial for product approval and compliance with national and global standards.
Our Environmental Risk Assessment Services in Vietnam Include:
- Phase I & Phase II environmental assessments
- PEC/PNEC calculations & exposure modeling
- Ecotoxicity evaluation & regulatory dossier preparation
- Integration with global submission strategies (MOH/DAV, ASEAN, WHO)
Integrating environmental compliance services early in development mitigates approval risks and submission delays, enhancing regulatory confidence for sponsors and CROs. Zenovel offers scientifically robust documentation for global submissions and lifecycle compliance, establishing itself as a reliable partner for accurate environmental assessments in Vietnam.
EU QP Support Services for Batch Release Compliance in Vietnam
Offering Expert EU QP Solutions for Vietnam Pharmaceutical Compliance
Ensuring regulatory compliance for Vietnamese pharmaceutical companies requires expert EU QP Support Services, as a Qualified Person (QP) certification is essential for EU exports. This certification ensures adherence to GMP standards before product release in the European market.
Our EU QP Support Services in Vietnam Include:
- Batch record review & GMP compliance verification
- Deviation assessment & quality documentation review
- Coordination with EU Qualified Persons for final certification
- Alignment with EU GMP Annex 16 and global regulatory expectations
- Support for Vietnamese manufacturers targeting EU markets under MOH/DAV export guidelines
Zenovel leverages extensive expertise in batch release compliance to minimize approval delays and compliance risks, facilitating efficient product distribution in European markets. We support Vietnamese pharmaceutical companies, CDMOs, and sponsors in upholding regulatory standards throughout the product lifecycle, positioning ourselves as a reliable QP support partner for compliant and efficient batch releases in the EU market.
Regulatory Gap Analysis Services in Vietnam for Regulatory Compliance.
We are Identifying Gaps and Strengthening Compliance in Vietnam
To identify compliance gaps early to improve submission success rates, the requirement for expert Regulatory Gap Analysis Services for pharmaceutical and biotech companies in Vietnam is significant. Zenovel assists in the evaluations of clinical, non-clinical, and CMC documentation to ensure compliance with the Ministry of Health, the Drug Administration of Vietnam, Circular No. 50/2025/TT-BYT, ASEAN guidelines, and global standards crucial for timely national and international approvals.
Our Regulatory Gap Analysis Services in Vietnam Include:
Dossier completeness & data integrity
SOP compliance & submission readiness
Gaps in IND, NDA, ANDA, and BLA applications (for global submissions)
Actionable remediation plans for compliance optimization
Alignment with MOH/DAV, ASEAN, ICH, and WHO requirements
Zenovel provides structured services for regulatory compliance readiness, assisting sponsors in reducing approval risks and enhancing submission quality. We identifies deficiencies and offers practical solutions to improve regulatory positioning, ensuring documentation is audit-ready and globally compliant.
We serve as a reliable partner for gap analysis in Vietnam to prevent regulatory delays and facilitate approval-ready submissions.
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