Life Sciences Compliance.
We listen. We get it.
We're here to help.
Practical Solutions.
Reality.
"We just need a few guardrails."
Emerging Companies
Pre-commercialization is a key time to ensure corporate, HCP interaction and privacy compliance, while building infrastructure for product launch. “Waiting until approval or clearance” could raise notable risk both in R & D activities and commercialization – and could significantly hamper business goals.
We specialize in tailoring right-size, right-time, efficient compliance programs and smart tools for companies transitioning from private to public and research to commercial.
About Us
The team at Partita Consulting has been working in, and with, life science companies of every size for well over 25 years. We have first-hand experience building, delivering, assessing and enhancing compliance programs in pharma, biotech, med device, diagnostics, blood and tissue products in over a dozen therapeutic areas at companies ranging from start-ups to the largest of pharmaceutical companies - and every size in between. We have assisted companies under Corporate Integrity Agreements (CIAs) and helped many more avoid them.
We believe success in compliance is built on open collaboration, intelligent risk understanding and awareness and efficient execution.
We care deeply about ensuring that compliance programs deliver what is needed, when it's needed and modern compliance tools and services that are right for your unique market and goals.
Holly Kramen, JD
Holly has worked passionately at building and evolving life science compliance programs for over 25 years, focusing on culture, partnership, operational integration, practicality, common sense and a bit of humor. She has led compliance and legal departments tailoring, every aspect of corporate, commercial and medical affairs compliance in companies ranging from biotech start-ups to devices and diagnostics to big pharma. She has served as Chief Compliance Officer and Compliance Lead at a half dozen companies and held as many simultaneous Counsel and Privacy roles as well. She has also had leading firm advisory positions. She teaches multiple topics in the Seton Hall Law School Healthcare Compliance program.
Chuck Bell, JD, BSN
Chuck has dedicated over 20 years to providing pharmaceutical, medical device, diagnostic and biotech companies with Commercial Compliance and Risk Mitigation guidance. He brings a unique perspective having served as a Compliance Officer for a biological company, consulting companies under Corporate Integrity Agreements (CIA) – submitting over 20 CIA reports to the OIG. Chuck specializes in enterprise-wide control assessments, identifying functional risks and implementing controls opportunities for technology enhancement and development/enhancement of policies and procedures. He combines a clinical background as a registered nurse, law degree and over 10 years with a Big 4 management consulting firm developing and assessing compliance controls.
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202-304-2850
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