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.


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.