Service Capabilities
CTD and eCTD Dossier Preparation
Comprehensive authoring, publishing, and compilation of CTD Modules 1–5 for initial applications and lifecycle maintenance, ensuring accuracy, compliance, and submission-readiness.
Regulatory Intelligence & Monitoring
Continuous surveillance of global regulatory changes, coupled with interpretation of authority expectations and strategic guidance to support proactive decision-making and effective regulatory risk mitigation.
Regulatory Submissions & Lifecycle Management
End-to-end coordination and delivery of regulatory submissions, including initial approvals, renewals, variations, annual reports, and post-marketing obligations supported by high-quality
documentation.
Global Regulatory Strategy
Strategic, tailored regulatory planning to facilitate geo-expansions and line extensions, integrating clinical development goals, scientific positioning, and commercial timelines.
Labeling & Product Information Compliance
Development and maintenance of labeling content, including CCDS/CCDS updates, SmPC and
PIL alignment, and packaging/artwork review to maintain consistency across markets.
Inspection & Audit Readiness Support - QA
Comprehensive preparation for regulatory inspections through documentation support, training, mock review exercises, and evidence compilation for smooth, confident audit outcomes.
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