Clinical Development Strategy and Planning
Making the most of every piece of the regulatory puzzle.
When it comes to clinical development, we’re dedicated to getting every moment right. And we have the people to get you there. The seasoned advisors on our Regulatory Consulting Services team have decades of experience helping teams interpret new and existing guidance throughout the process – and throughout the world. In fact, many of them are former FDA, EMA, and NMPA regulators themselves.
Our services include:
Regulatory Strategy
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 (India, US, EU, China, Japan, Canada, and emerging markets-ROW), submission planning (eCTD), patient-focused development.
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
Health Authority Meetings
Preparation support, briefing documents, rehearsals, meeting attendance, and health authority liaison
Quality system inspection
Strategy and inspection readiness
Stakeholder Management
Drug safety, technical operations, medical and commercial stakeholder management
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