Regulatory Affairs & Pharmacovigilance Consulting in China

PV Solutions Limited provides consulting services to pharmaceutical companies on regulatory affairs and pharmacovigilance in China.

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What We Offer

Services for pharmaceutical companies operating in or entering the Chinese market smoothly.

Regulatory Affairs Consulting

Expert guidance on navigating China's GVP requirements, regulatory submissions, and compliance with NMPA standards. We provide comprehensive support for regulatory intelligence, gap analysis, product registration and ongoing regulatory interactions with Chinese authorities.

Pharmacovigilance Strategy & Operations

Comprehensive safety monitoring frameworks including QPPV/RPPV designation, adverse drug reaction (ADR) management, PSUR/PBRER, literature search and post-market surveillance strategies compliant with China's evolving pharmacovigilance regulations.

China PV Inspection & Audit Support

Preparation and support for pharmacovigilance inspections and audits. We help navigate the PV inspection framework, including documentation review, compliance assessment, and inspection readiness. We conduct remote or on-site audits of your local partners, eliminating the need for you to travel to China.

Ongoing Compliance & Monitoring

Continuous monitoring and compliance support to maintain regulatory standing throughout the product lifecycle. Trading advisory. Sourcing and supply chain services

Expertise in China's Regulatory & Pharmacovigilance Framework

PV Solutions Limited brings specialized expertise in China's complex pharmacovigilance and regulatory environment including NMPA compliance, data gap assessment, GVP requirements, PV inspection. We ensure comprehensive compliance with Chinese regulatory standards and pharmacovigilance requirements throughout your product lifecycle.

NMPA Submissions & ICH Compliance

Expert preparation of regulatory submissions including ICH-eCTD format and GMP compliance documentation for CDE-NMPA review

China Pharmacovigilance Systems

Design and implementation of PV systems including PSMF, QMS and ICSR reporting compliant with Chinese regulatory requirements

Regulatory Authority Coordination

Expert liaison with NMPA and provincial authorities for PV inspections, audits, and regulatory compliance management

China Market & Regulatory Strategy

Strategic guidance on market entry, product lifecycle management, and long-term regulatory strategy in China's evolving pharmaceutical landscape

About PV Solutions Limited

PV Solutions Limited help global pharmaceutical companies navigate China's complex regulatory landscape with confidence. Backed by our local experts with decades of combined experience in pharmacovigilance and regulatory affairs, we provide tailored consulting services that enable pharma companies to enter and succeed in the Chinese market.

Our team brings deep expertise in regulatory submissions, safety monitoring strategies, and local compliance coordination. We are committed to supporting our clients' success in the Chinese market through tailored, professional consulting services.

Contact

We'd love to hear from you. Whether you're planning market entry in China, conducting a GVP audit, or need regulatory guidance, reach out to PV Solutions Limited to discuss your project.