Offerings

Strategic consulting services that help customers define the optimal regulatory pathway for products and portfolios while transforming regulatory organizations for future readiness. The offering spans product-level regulatory strategy, portfolio planning, regulatory intelligence, and health authority engagement, alongside regulatory operating model and process consulting to optimize people, processes, governance, and technology across the regulatory function. Product & Portfolio Strategy – Regulatory pathway selection – Global development strategy – Market prioritization – Regulatory due diligence – Regulatory gap assessments – Health authority engagement strategy – Scientific advice planning and support – Portfolio optimization – Regulatory intelligence & policy monitoring Regulatory Transformation & Process Consulting – Process design and optimization – Governance framework design – Regulatory organization design – Digital transformation and technology enablement – Labeling operating model design – Due diligence process design – Change management and implementation support

End-to-end regulatory support for obtaining initial marketing authorizations and enabling successful product launches across global markets. The offering covers regulatory planning, dossier preparation, submission execution, health authority interactions, and local market entry support, ensuring efficient approvals and timely commercialization. Initial Registration & Submission Services – Regulatory submission strategy – Global submission planning and coordination – Marketing Authorization Applications (MAA/NDA/BLA/ANDA) – Initial registration submissions – Dossier authoring and compilation – eCTD publishing and validation – Submission management – Health authority submission support – Agency meeting coordination Market Entry & Affiliate Support – Local affiliate coordination – MAH and Local Legal Representative services – Country-specific application support – GMP certificate support – Market entry regulatory support

Comprehensive country- and region-specific regulatory services that ensure products remain compliant with local regulatory requirements throughout their commercial lifecycle. The offering provides dedicated affiliate support for regulatory execution, health authority engagement, license maintenance, and market-specific compliance activities. Services include: – Local regulatory submissions – Health authority interactions – Affiliate regulatory support – Regulatory correspondence management – Local dossier maintenance – Country-specific regulatory execution – Regulatory commitment tracking – License maintenance – MAH maintenance services – Local Labeling services – Artwork coordination – Translation and localization support – Legalization and notarization – Local regulatory intelligence

End-to-end lifecycle management services that support regulatory compliance following product approval. The offering enables efficient management of post-approval changes through strategic planning, submission execution, publishing, and coordination across global and local markets while ensuring continued regulatory compliance. Lifecycle Submission Management – Global lifecycle management – Variation management (IA/IB/II, CBE, PAS, etc.) – Renewals – Annual reports – Change management – CMC lifecycle management – Line extensions – Product transfers – Marketing authorization transfers – Withdrawal submissions Regulatory Operations & Compliance – Health authority query responses – Submission management – eCTD publishing – Regulatory publishing QC – Regulatory data management – RIMS support – Commitment tracking – Global coordination – Regulatory metrics and reporting