Navigating Complex Regulatory Landscapes
Trust our comprehensive regulatory services to ensure compliance and streamline your product registration process.
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Data Analytics & Regulatory Intelligence
We provide a rich database to analyse approval trends and timeline projections.
Pre-submission Strategy
We offer regulatory landscape, product classification, requirements consultation and submission route assessment.
Pharmacovigilance Management
We do adverse events reporting, surveillance audits by local authorities, and offer support for international pharmacovigilance requirements.
Authority Engagement, New Registration & Marketing Authorisation Transfer Application
We ensure submission of dossier management, local registration application, management authority enquiries and registration timeline management.
Post-Approval Changes & Maintenance
We manage post-approval change submission, labelling change & safety updates submission, management of change implementation & transition as well as licence renewal & dossier maintenance.
Market Entry Strategy Consultation
Our high adaptability teams collaborate with local authorities to introduce novel products through strategic registration pathways for rapid market entry.
Dossier Preparation & Registration Submission
We have experienced teams with more than 3,000 new registration and marketing authorisation transfer approvals.
Regulation Changes Impact Assessment
We establish a process to anticipate impact of new regulations change for transition planning with minimal disruption to business.
Regulatory Commercial Supply Coordination
We ensure dedicated project managers liaising regulatory readiness on product launch, mapping post-approval changes to supply schedule, and more, to ensure market compliance.
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Zuellig Pharma News & Insights
Stay up-to-date with the latest news about Zuellig Pharma and the healthcare industry in Asia, as our experts from across the region share their insights.