Our goal is to pave the way for early access to innovative and meaningful healthcare while providing full regulatory life cycle management.
Our regulatory affairs teams in 13 Asian markets provide customised support and leadership for healthcare regulatory compliance. With over 3,000 completed product registrations and marketing authorisations, we have the expertise to guide you through the registration process and accelerate market access for patients in Asia. We work closely with industry associations and local regulatory authorities to ensure compliance with new regulations.
We provide end-to-end services from registration planning to post-approval for drugs, medical devices, supplements, and cosmetics.
Data Analytics & Regulatory Intelligence
We provide a rich database to analyse approval trends and timeline projections.
We offer regulatory landscape, product classification, requirements consultation and submission route assessment.
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.
Regulatory compliance is an evolving process of continuous improvement. In providing healthcare regulatory services, we collaborate with our partners at every stage of the regulatory process. In doing so, we regularly review our work to improve efficiency and quality.
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.