RONALD B. NILAND| President, JANA Life Sciences

At JANA Life Sciences, we believe that exceptional documentation and training solutions emerge from a foundation of deep industry understanding, methodical processes, and genuine partnership with our clients. Having spent over three decades in life sciences—supporting research, development and commercialization efforts at Pfizer, Amgen, Genentech and Gilead Sciences—I've witnessed firsthand how critical precise documentation is to bringing life-changing therapeutics to patients who need them most.

Whether supporting regulatory filings for breakthrough treatments like Avastin and Herceptin, developing companion diagnostics that ensure the right patients receive the right therapies, or creating documentation for cutting-edge medical technology including cardiac monitoring devices and wearables, I've learned that success always comes down to the same principle: methodical excellence executed with human understanding.

Methodical Excellence in Life Sciences Documentation & TRAINING

This philosophy guides everything we do at JANA Life Sciences. We don't just create documents and training programs—we craft solutions that accelerate your time-to-market while ensuring regulatory compliance. From 3D medical device modeling completed in 8 business days to comprehensive LIMS validation protocols, our team combines 50+ years of proven technical expertise with the regulatory precision that life sciences demands.

Our experience spans the full spectrum of modern medtech innovation: companion diagnostics that guide precision medicine decisions, sophisticated cardiac monitoring systems, wearable devices that transform patient care, and the complex documentation ecosystems that bring these breakthrough technologies to market safely and efficiently.

Beyond documentation, we help companies develop better products and services more expeditiously and cost-effectively. Our methodical approach identifies optimization opportunities throughout your development lifecycle, ensuring your innovations reach patients faster while maintaining the highest quality standards. Please scroll down to see our complete Credo.

Strategic Global Reach with Local Control

Our family-owned structure enables something smaller competitors can't match: a nimble near-shore model through our JANA Mexico operations. And while larger firms may try to mirror it, ours is dovetailed tighter through our QMS and significant interactions between our San Antonio headquarters and Querétaro facilities. This approach delivers significant cost advantages while maintaining the quality standards and regulatory compliance your projects demand. For companies expanding into Latin American markets, we offer cultural insights and regional expertise that can accelerate your global growth strategy—all while ensuring seamless integration with your U.S.-based operations.

Your Direct Connection

I want you to know that JANA Life Sciences operates as an extension of your team, not just another vendor. My door—and inbox—are always open. Whether you're facing a complex FDA submission deadline for a companion diagnostic, need strategic guidance on documentation architecture for wearable medical devices, or simply want to discuss how we can better support your mission, please reach out to me directly.

Having managed global programs across virtual teams and guided regulatory submissions from IND through commercial launch, I understand the pressures you face and the precision your work demands. More importantly, I know how the right documentation partner can transform those challenges into competitive advantages.

Our Commitment to You

Every project we undertake reflects our family-owned values and ISO-certified processes. We don't pursue quick fixes—we build lasting solutions that grow with your organization. Whether you're an emerging medtech or biotech company preparing for your first FDA filing or an established pharmaceutical company managing complex global operations, we bring the same methodical approach that has guided successful therapeutics from concept to patient.

Your success is our success. Your mission to advance science and improve patient lives is why we exist.

Thank you for considering JANA Life Sciences as your partner in methodical excellence.

Ron Niland, MBA, PMP, Six Sigma Lean
President, JANA Life Sciences
Bringing methodical excellence to life sciences documentation and training

Questions? Challenges? Opportunities? I'm here to help.
Direct: (805) 405-4115 | rniland@janalifesciences.com
Main: (210) 616-0083

Please feel free to reach out to me and connect through LinkedIn

KEITH PARENT | FOUNDER AND CEO AT COURT SQUARE GROUP

Under Keith’s leadership Court Square Group has built a reputation as a leader in the Life Sciences industry. With over 35 years of technology and leadership experience Keith has a clear understanding of regulatory challenges and the Good System Practices (GSPs) required to maintain a Qualified state for their company’s clients.

Under Keith’s direction Court Square has implemented and maintained a myriad of enterprise-level preclinical, clinical and regulatory systems. Relevant efforts include Global Submission systems, eCTD systems, FDA Gateways, Adverse Event Reporting systems, Clinical Trial systems, and Longitudinal Patient Registry development systems - in total involving over 100,000 users and 5,000 servers.   Recently Keith has been heavily involved in developing AI based solutions for the Life Science industry.

Keith has been a consultant to Pfizer Pharmaceuticals for over 30 years and has held other leadership positions in the Life Science Industry. He is a regular guest speaker at many Life Science events and a thought leader for companies that are building solutions in the Life Science Industry. Keith holds a Masters Degree in Computer Science (MSCS) from Rensselaer Polytechnic Institute and a Bachelor of Science in Computer Science from Siena College.

Monica C. Hayes, PMP, LSSBB, SCC

Monica Hayes is the Founder and Managing Principal of Fusion Success Group, a consultancy known for its expertise in process development, project management, coaching, and training across various sectors. With over 17 years in Operations, R&D, Engineering, and Consulting, Monica has spearheaded initiatives that encompass process optimization, program management, strategic business transformation, and lean implementation. These efforts have consistently resulted in significant efficiency gains, innovative growth, and profound business transformation for her clients.

Monica's educational pedigree includes a B.S. in Mechanical Engineering from The University of Texas at Austin and an M.S. in Mechanical Engineering from UTSA. Complementing her formal education, she holds credentials as a PMP, Lean Six Sigma Black Belt, GrowthWheel Business Advisor, and Marshall Goldsmith Executive Coach. Dedicated to industry advancement, she was honored as a Top 40 Under 40 by the San Antonio Business Journal in 2022. She’s also an active contributor to industry organizations, serving on distinguished boards such as The Health Cell and the San Antonio Lighthouse for the Blind.

Outside her professional pursuits, Monica is an avid mentor and speaker, delving into themes such as Continuous Improvement, Career Development, and Entrepreneurship. Her personal endeavors highlight a tapestry of interests, from dedicated motherhood to savoring culinary and musical arts, and preserving her athletic edge, dating back to her NCAA days as a Division 1 track and field athlete at UT Austin.