Regulatory Strategy & Development 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: 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
WHITE PAPER / COMMERCIALIZATION

HOW CAN THE BIOSIMILAR CONCEPT BE APPLIED TO MORE COMPLEX PROTEINS SUCH AS MONOCLONALS?

An overview of the biosimilar concept, focused on the European Union's approval process for "similar biological medicinal products."

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Regulatory services brochure

Regulatory, Development and Commercial 
Expertise. Operational Excellence. One Source.

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The State of Germline Gene Editing. What We Don’t Know!

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Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?

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Points to Consider When Referencing a Master File in FDA Regulatory Submissions (IND, BLA, NDA)

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Points to Consider for Establishing Biotechnological/Biological Product Comparability

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Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products

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We are always available for a conversation.

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