Limpidity Biosciences is a consulting firm that focuses on development for products regulated by the FDA.
I strive to provide clarity to complex problems and communicate solutions in a clear way for all stakeholders.
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Let me work with you on innovative strategies and operational excellence for your development program.
Together we can be clarifying agents; a lighthouse providing a reference point through changes, and a bridge over your challenging problems.
Are you ready to begin?
Services
Regulatory Strategy
I can conduct comprehensive regulatory development for your product including incorporation of reference drug information to streamline development.
Regulatory Compliance
I can implement regulatory quality systems, as well as compliance with FDA administrative requirements including the Pediatric Research Equity Act
Leadership
I can provide fractional leadership for your growing enterprise. I develop staff and implement regulatory submission planning, content production, and eCTD publishing.
Development Planning
Starting with a Target Product Profile, I can develop a project plan for your product, including CMC, device, nonclinical, and clinical development.
Product Exclusivity
I can incorporate patent and regulatory exclusivity into your product development plan.
Diligence
I can evaluate regulatory, technical, and patent data for external opportunities.
I can help you prepare and present data to potential partners.
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