Pharmacovigilance Consulting Services
Cisema supports pharmaceutical companies with end-to-end pharmacovigilance (PV) services tailored to the evolving regulatory environment in China and the Asia Pacific region. We help you establish, maintain, and optimize pharmacovigilance systems that align with local requirements, including those of the NMPA in China, and global best practices, from clinical development through post-marketing surveillance.
We combine regional insight with global expertise to ensure regulatory compliance, reduce adverse event risk, and uphold patient safety. Whether entering the Chinese market or expanding throughout Asia Pacific, our tailored consulting services cover the full range of pharmacovigilance activities required to manage drug safety, maintain product licenses, and ensure compliance with evolving regulatory guidelines.
Our Pharmacovigilance Consulting Services in China & Asia Pacific
Signal Management
Early identification and evaluation of safety signals is essential in the dynamic regulatory environment of China and Asia Pacific. We offer robust signal detection solutions supported by localized knowledge and up to date interpretation of regulatory authorities' expectations.
Risk Management Plans (RMPs)
We assist in the development and localization of RMPs in line with both Chinese and regional regulatory requirements and industry best practices. Our approach to risk management ensures that your products retain a positive safety profile across all relevant markets.
Individual Case Safety Report (ICSR) Management
Our team handles the end-to-end lifecycle of ICSRs, including the intake of adverse event information, case processing, assessment, and submission. We ensure timely and accurate safety reporting in accordance with China’s NMPA and other Asia Pacific regulatory authorities, including strict local timelines and formats.
Clinical Trial Safety Monitoring
We provide end-to-end pharmacovigilance services for clinical trials, including serious adverse event monitoring, safety data analysis, and regulatory liaison. Our services help maintain patient safety and ensure that your clinical trials progress without regulatory delays.
PV System Audits & CAPA
Our audits assess your pharmacovigilance system against local and global standards. We help implement standard operating procedures, work instructions, and CAPAs to strengthen your pharmacovigilance operations and reduce the risk of non-compliance. We help ensure ongoing inspection readiness and regulatory conformity across multiple Asia Pacific jurisdictions.
Post-Marketing Surveillance
Cisema offers real-world safety monitoring and reporting to ensure long-term drug safety and compliance after product launch. Our post marketing surveillance services include managing periodic safety update reports, tracking emerging adverse effects, and ensuring timely reporting to regulatory authorities.
Qualified Person for Pharmacovigilance (QPPV) Services
We provide qualified person for pharmacovigilance (QPPV) services in China and select Asia Pacific markets, ensuring that your pharmacovigilance systems remain compliant, fully documented, and audit-ready, including the preparation of a pharmacovigilance system master file.
Why Work with Cisema?
Local expertise with global reach
Our bilingual teams bridge international quality standards with local regulations
Proven track record
Over 20 years supporting market approvals and compliance in China and Asia Pacific
End-to-end solutions
From system setup to post-market surveillance, we ensure quality management and regulatory compliance throughout the product lifecycle
Industry breadth
Cross-sector expertise in life sciences, food, veterinary, consumer and industrial goods
Frequently Asked Questions
Our pharmacovigilance consulting includes support across the full product lifecycle, from clinical trial design to post marketing surveillance, ensuring effective safety operations, audit readiness, and compliance with local and global requirements.
Yes. We manage trial safety oversight, including SAE reporting and safety data analysis, in compliance with country-specific requirements throughout China and Asia Pacific.
We prepare and submit Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) in accordance with local regulatory requirements across the region.
Yes. We provide qualified person (QPPV) and responsible person services in China and select Asia Pacific markets, ensuring local oversight and regulatory communication with regulatory authorities.
Varying regulatory requirements, language barriers, and local compliance obligations create complexity. We guide clients through country-specific expectations, supporting robust pharmacovigilance operations that meet regulatory and industry standards.
We document, assess, and report adverse events and serious adverse events in compliance with national regulatory authorities, reducing risk and supporting ongoing regulatory compliance.
Yes. Our post-marketing surveillance services cover multiple Asia Pacific jurisdictions, helping you meet ongoing safety obligations with real-world data analysis and regional reporting expertise.
We conduct gap analyses and implement CAPAs to restore regulatory compliance and mitigate the risk of enforcement actions across jurisdictions in China and Asia Pacific.
Our pharmacovigilance consultants bring deep regional and technical expertise, reducing your internal workload and enhancing compliance across pharmaceutical products in Asia Pacific.
We offer ongoing support, training, and audits to help your pharmacovigilance systems evolve in line with regulatory changes and emerging drug safety concerns, and the latest industry developments.
Request a Proposal from Our Pharma Team
Let Cisema help turn your plans into reality.
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