Regulatory support
Would you like to secure your growth by registering products and overcoming regulatory challenges? Our team of regulatory experts provide you with broad technical registration expertise and in-depth knowledge of local regulations.
Through our ongoing liaisons with regulatory authorities, we can manage your dossiers (we currently hold many marketing authorizations on behalf of our clients) and safeguard your interests. You benefit from having a single regional point of contact for all regulatory matters.
Pre-registration
Preparing smooth market entry by:
Regulatory feasibility assessment
Labeling requirement assessment
Registration
Handling the entire product registration through:
Dossier preparation
Compliance check
Product sample submission
Dossier submission
Registration follow-up and monitoring
Regulatory approval
Post-marketing
Ensuring products follow the regulations throughout the life cycle by:
Marketing Authorization (MA) holding, maintenance and transfer
Variations (minor and major)
Renewal
Advertising compliance check