Pharmacovigilance & Post-Market Surveillance
Pharmacovigilance and post market surveillance are essential for safeguarding public health, protecting consumers, and maintaining regulatory compliance across a product’s entire product lifecycle. Whether you are a pharmaceutical company monitoring adverse reactions, a medical device manufacturer tracking real-world performance, a cosmetics brand complying with cosmetovigilance rules, or a producer of health foods, veterinary products, industrial goods, or consumer items, Cisema provides the expertise and systems to keep you compliant and competitive across the Asia Pacific region.
Our comprehensive services cover pharmaceuticals, biotechnology products, medical devices and in-vitro diagnostics (IVDs), quasi-drugs, veterinary medicines, cosmetics and ingredients, health foods and supplements, and industrial and consumer goods. We help you establish, operate, and optimize pharmacovigilance, safety surveillance and quality monitoring systems that align with evolving local regulations and global expertise.
Pharmacovigilance Services for Pharmaceuticals & Biotech Products
Cisema delivers end-to-end PharmacoVigilance (PV) services tailored to China’s NMPA requirements and Asia Pacific regulatory frameworks. Our tailored consulting services cover the full spectrum of pharmacovigilance activities from safety data collection and risk management to regulatory reporting and license maintenance.
Our pharmacovigilance services include:
By integrating PV into your quality systems, you ensure continuous safety oversight, minimize adverse health consequences, and protect your marketing authorizations.
Post Market Surveillance for Medical Devices & IVDs in China, Hong Kong, Taiwan, South Korea & ASEAN
Cisema provides end-to-end Post Market Surveillance (PMS) support for medical devices and IVDs across China, Hong Kong, Taiwan, South Korea and the six ASEAN markets we serve: Singapore, Malaysia, Thailand, Vietnam, Indonesia, and the Philippines. Our expertise covers region-specific regulatory requirements, reporting obligations, and technical documentation standards to help you maintain safety, performance, and regulatory compliance throughout the product lifecycle.
Our medical device and IVD PMS services include:
We help manufacturers navigate challenges such as fragmented PMS data across multiple jurisdictions, varied reporting formats, and tight submission deadlines. Our multi-country approach ensures your devices remain compliant, market surveillance obligations are met, and your products retain uninterrupted market access across the regions we serve.
Quality & Regulatory Management for Quasi-Drugs in South Korea
We support manufacturers in achieving and maintaining compliance with Korean quasi-drug quality and regulatory requirements. Our team helps integrate Korean expectations into existing GMP, QMS, and SOP systems while supporting ongoing compliance activities and preparation for official MFDS inspections.
Our services include:
Cosmetovigilance for Cosmetics & Ingredients in China & Taiwan
China’s Cosmetic Supervision and Administration Regulation (CSAR) and Taiwan’s Food and Drug Administration (TFDA) requirements impose strict postmarket surveillance obligations to ensure ongoing cosmetic product safety and regulatory compliance. Cisema supports cosmetic brands and contract manufacturers in China and Taiwan by designing and managing cosmetovigilance systems that monitor, assess, and report adverse reactions throughout the product lifecycle.
Our cosmetovigilance services include:
By actively monitoring adverse event reporting platforms and training your teams on local obligations, we help safeguard consumer safety and protect your brand reputation in both China and Taiwan.
Post Market Surveillance & Vigilance for Health Foods & Supplements
Cisema provides full-service support to help manufacturers and importers of health foods and supplements in China meet State Administration for Market Regulation (SAMR) requirements. We establish and operate vigilance systems that track, document, and address adverse events and product-related safety issues after market entry, including monitoring product performance, verifying functional claims, and ensuring labelling and marketing materials remain accurate and compliant.
Our vigilance and PMS services for health foods and supplements include:
Our approach ensures that your health food products remain compliant, safe for consumers, and trusted in the Chinese market throughout the product lifecycle.
Vigilance, Safety, & Compliance for Veterinary Medicines & Products
Cisema provides end-to-end support to help manufacturers of veterinary medicines and related animal health products meet regulatory vigilance obligations. We design and manage robust systems to detect and address potential adverse events or quality concerns that could affect animal health, public health, or trade.
Our veterinary product vigilance and PMS services include:
By implementing a structured vigilance framework, we help ensure that veterinary medicines remain compliant, effective, and safe for use, while maintaining uninterrupted market access.
Quality & Regulatory Maintenance for Industrial Goods & Consumer Products
China’s Compulsory Certification (CCC), China Manufacturing License (SELO CML) and other approval systems require ongoing maintenance after market entry.
Our services include:
Why Work with Cisema?
One Partner, Full Lifecycle Support
From pre-market strategy to post-market compliance, we provide support to internal regulatory teams and ensure seamless lifecycle management.
Regional Reach, Global Presence
Based in Asia and Europe with a global team delivering global reach.
Cross-Industry Expertise
Pharma, biotech, medical devices, cosmetics, supplements, veterinary, industrial and consumer goods.
Proven Results
Over 20 years of regulatory submissions, regulatory expertise, and approvals to drive business success.
