A Practical Guide to Controlled Substance Compliance

Why Controlled Substance Compliance is more complex than ever

Navigating controlled substance regulations is becoming increasingly complex as legislation shifts toward structure-based definitions. Identifying analogues and generically defined compounds across large chemical libraries is no longer feasible with manual methods.

As regulatory frameworks evolve, even minor structural differences can significantly impact compliance status. This white paper explores the challenges behind this growing complexity and what it means for pharma organizations.

Learn how to better identify and manage controlled substances in an ever-changing regulatory landscape.

Key learning outcomes

Understand generic definitions in drug legislation and how regulators classify substances based on chemical structure

Learn how controlled substance analogues are identified through structural and pharmacological similarity

Explore structure-based legislation and global regulatory trends impacting drug control

Navigate real-world compliance challenges, including managing complex and evolving international regulations

Identify controlled compounds efficiently within large chemical libraries

Examine practical case studies

Discover computational approaches to compliance, including the use of Markush structures and cheminformatics tools

Apply scalable strategies to screen compound libraries and improve pharmaceutical compliance

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About the authors

Zofia Jordan

Zofia Jordan is currently an independent consultant for Compound Compliance, formerly she was Compound Compliance specialist for discovery compounds at GSK, where she has proven experience in managing both the physical handling and associated data around controlled compounds. As the Chair of the Controlled Substance Compliance Expert Community, Pistoia Alliance, she represented Pharma in talks with the Advisory Council on Misuse of Drugs to modify the Third Generation Synthetic Cannabinoid amendment, which finally came into law in November 2019, releasing thousands of compounds back into discovery libraries across pharma.

Ákos Papp

Ákos Papp is a chemical engineer through education, as he graduated from the Department of Chemical Engineering at Technical University of Budapest. Throughout his career he has always worked in the chemoinformatics area, both at the software development and from a user standpoint. Since joining Chemaxon in 2008, he was involved in several projects including: Marvin, Compound Registration and Biologics registration, and now he is the Product Manager of Compliance Checker, cHemTS and JChem for Office.

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.