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Clinical Development Strategy and Planning

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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.

We are always available for a conversation.

Let's discuss