• Regulatory Strategy: Global product development strategy, clinical, non-clinical, CMC, and regulatory gap analysis, due-diligence, product and indication prioritization, regulatory pathway optimization and acceleration strategy, global labelling (CCDS updates), marketing authorization applications (US, EU, China, Japan, Canada, and emerging markets-ROW), submission planning (eCTD), patient-focused development
• Health Authority Meetings: Preparation support, briefing documents, rehearsals, meeting attendance, and health authority liaison
• Quality system inspection: Strategy and inspection readiness
• Submission support: Storyboarding/key messaging, core submission preparation and authoring, original application publishing with lifecycle maintenance, lifecycle publishing, global dossier management, RTQs, and CTA core dossier development
• Stakeholder Management: Drug safety, technical operations, medical and commercial stakeholder management
• Mergers and Acquisitions: Planning, submission authoring, dossier collection, and stakeholder management