About

Pearl Pathways is all about accelerating life science product development. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our full-service central IRB supports all aspects of human research. We are an extension of our clients’ teams. We partner with the clinical team, in-house regulatory experts, the quality compliance specialists, the quality auditors, and the senior leadership team to get life saving devices, diagnostics and therapeutics to the market sooner.

Our talented team focuses on completing critical research, ensuring high quality and efficient manufacturing of products, accelerating global product registrations, and keeping our clients up to date on current regulatory and quality compliance trends and best practices for life science product development.

What shapes our behaviors each day?

  • Driving improved value and efficiency in product development
  • Accelerating regulatory pathways
  • Setting the bar on quality compliance standards
  • Protecting human subjects
  • Enabling smart, effective and high quality product development

How are we different?

  • Partnership and service mindset
  • Staff expertise with decades of regulatory, quality compliance, clinical and product development experience
  • Founder with extensive sponsor background coupled with service delivery experience
  • Serve a breadth of clients from small startups to large multinationals including biopharma, device and diagnostic companies
  • Breadth of services offered to support our clients throughout the product development and research paths
  • Thoughtful, proactive business model created to solve problems
  • Midwest headquarters
  • Efficient. Ethical. Experienced.
  • Nimble. Flexible. Responsive.

The August K. Sommer House

Pearl Pathways is located near downtown Indianapolis in a beautiful historic building.

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Vision

Pearl Pathways is the recognized trusted advisor and preferred partner for enabling innovative and expedited life science product development.

Mission

Ensure our clients successfully navigate the highly regulated life science environment by balancing risk, speed to market, and cost to achieve their business goals.