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.
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Pre-submission Strategy

We offer regulatory landscape, product classification, requirements consultation and submission route assessment.
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Pharmacovigilance Management

We do adverse events reporting, surveillance audits by local authorities, and offer support for international pharmacovigilance requirements.
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Authority Engagement, New Registration & Marketing Authorisation Transfer Application

We ensure submission of dossier management, local registration application, management authority enquiries and registration timeline management.
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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.

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Market Entry Strategy Consultation

Our high adaptability teams collaborate with local authorities to introduce novel products through strategic registration pathways for rapid market entry.
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Dossier Preparation & Registration Submission

We have experienced teams with more than 3,000 new registration and marketing authorisation transfer approvals.
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Regulation Changes Impact Assessment

We establish a process to anticipate impact of new regulations change for transition planning with minimal disruption to business.
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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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