Event
FDLI Enforcement, Litigation and Compliance Conference
December 4  -  December 5, 2025
                                            
                    
Washington, D.C.
Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.
Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.
Our multi-disciplinary early phase approach accelerates the path to proof of concept by integrating diverse expertise to optimize study design, generate robust clinical evidence, and reduce gaps between development phases.
We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance. We design patient-informed protocols that remove participation barriers, accelerate enrollment, and increase the likelihood of successful drug launches.
Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, creating customized pathways to maximize global market reach throughout your product's lifecycle.
We enhance your product's value story through post-approval studies and holistic lifecycle management services that satisfy regulators and payers while building stakeholder trust and maximizing your drug's market impact throughout its entire lifecycle.
We bring together experienced cross-functional experts to implement best practices, process simplifications, and technology standardization that accelerate timelines and improve quality.
Get the personal, responsive, and committed approach of a small CRO, with all the benefits of a large CRO, to help you develop life-changing treatments for patients.

Clinical Trialblazers
Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life.
Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.
Our team delivers high-quality clinical trials through forward-thinking medical expertise across multiple indications by combining strategic insight with operational excellence to support programs of all sizes.
Our infectious disease and vaccines cro services help treat and prevent life-threatening illnesses. Learn how our team of experts can aid in any complex trial.
Discover our inflammation and immunology CRO services. We bring agile support and a unique MOA-driven model to inflammation and immunology.
Parexel is a leading Oncology CRO with more than 80 ex-agency regulators and nearly 2,500 sites globally. Learn more about our oncology indications.
As a leading neuroscience CRO, we leverage global site relationships, specialized resources, and indication-specific expertise to accelerate breakthroughs in neurological and psychiatric treatments for patients worldwide.
Our experts help you stay at the forefront of the industry — and ahead of change.

Optimizing the clinical research workforce: An industry analysis by Parexel
At the heart of Parexel sits the world’s most unique insight-generation engine: our people.
Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions.
Clinical trials provide patients with access to innovative investigational treatments that advance medical research. Participation requires careful consideration that weighs both the benefits and risks.

Patient Stories
Clinical study participation represents a deeply personal decision with potentially far-reaching impact, as evidenced by these inspiring individual stories that highlight both the life-changing potential for participants and the broader advancement of healthcare for all.
Want to collaborate with us to offer clinical trials at your site? We would welcome the opportunity to discuss.

Enabling successful sites
Our Enabling Successful Sites thought leadership series pairs site representatives with clinical operations experts to identify root causes of investigative site challenges and develop collaborative solutions.
We are one of the largest CROs in the world, speeding life-changing medicine to market by engaging patients With Heart™. Learn about who we are, what we do, and what we believe.
With decades of biopharmaceutical leadership experience and a deep dedication to patients, our executive team drives us forward in delivering better trials, faster.
Find key information on our policies, strategies, pay data, and more.
Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.
Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.
Our multi-disciplinary early phase approach accelerates the path to proof of concept by integrating diverse expertise to optimize study design, generate robust clinical evidence, and reduce gaps between development phases.
We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance. We design patient-informed protocols that remove participation barriers, accelerate enrollment, and increase the likelihood of successful drug launches.
Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, creating customized pathways to maximize global market reach throughout your product's lifecycle.
We enhance your product's value story through post-approval studies and holistic lifecycle management services that satisfy regulators and payers while building stakeholder trust and maximizing your drug's market impact throughout its entire lifecycle.
We bring together experienced cross-functional experts to implement best practices, process simplifications, and technology standardization that accelerate timelines and improve quality.
Get the personal, responsive, and committed approach of a small CRO, with all the benefits of a large CRO, to help you develop life-changing treatments for patients.

Clinical Trialblazers
Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life.
Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.
Our team delivers high-quality clinical trials through forward-thinking medical expertise across multiple indications by combining strategic insight with operational excellence to support programs of all sizes.
Our infectious disease and vaccines cro services help treat and prevent life-threatening illnesses. Learn how our team of experts can aid in any complex trial.
Discover our inflammation and immunology CRO services. We bring agile support and a unique MOA-driven model to inflammation and immunology.
Parexel is a leading Oncology CRO with more than 80 ex-agency regulators and nearly 2,500 sites globally. Learn more about our oncology indications.
As a leading neuroscience CRO, we leverage global site relationships, specialized resources, and indication-specific expertise to accelerate breakthroughs in neurological and psychiatric treatments for patients worldwide.
Our experts help you stay at the forefront of the industry — and ahead of change.

Optimizing the clinical research workforce: An industry analysis by Parexel
At the heart of Parexel sits the world’s most unique insight-generation engine: our people.
Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions.
Clinical trials provide patients with access to innovative investigational treatments that advance medical research. Participation requires careful consideration that weighs both the benefits and risks.

Patient Stories
Clinical study participation represents a deeply personal decision with potentially far-reaching impact, as evidenced by these inspiring individual stories that highlight both the life-changing potential for participants and the broader advancement of healthcare for all.
Want to collaborate with us to offer clinical trials at your site? We would welcome the opportunity to discuss.

Enabling successful sites
Our Enabling Successful Sites thought leadership series pairs site representatives with clinical operations experts to identify root causes of investigative site challenges and develop collaborative solutions.
We are one of the largest CROs in the world, speeding life-changing medicine to market by engaging patients With Heart™. Learn about who we are, what we do, and what we believe.
With decades of biopharmaceutical leadership experience and a deep dedication to patients, our executive team drives us forward in delivering better trials, faster.
Find key information on our policies, strategies, pay data, and more.
 Event
December 4  -  December 5, 2025
                                            
                    
Washington, D.C.
The FDLI Enforcement, Litigation, and Compliance Conference, held in December in Washington, DC, is a key annual event that brings together legal, regulatory, and compliance professionals from across the FDA-regulated industries. The conference focuses on current enforcement trends, litigation developments, and compliance strategies, offering insights from government officials, industry experts, and legal practitioners. It provides a valuable platform for networking, thought leadership, and staying informed on the evolving regulatory landscape, with both in-person and virtual attendance options available.
Schedule a meeting below and meet our site experts at the Parexel booth! You can also join our session – details are listed below!
Tala H. Fakhouri, Ph.D., M.P.H.
Vice President Consulting, AI & Digital Policy, Real-World Research
Thursday, Dec. 4 from 11:20a.m. – 12:20p.m.
Title – Smart Compliance, Smarter Enforcement: AI in Industry and at FDA
As industry increasingly deploys AI tool in quality systems, regulatory submissions, and compliance workflows, new challenges are emerging around data integrity, audit trails, and model transparency. At the same time, FDA is expanding its own use of AI – including the Elsa tool – to identify violations, detect data anomalies, and support enforcement actions, as seen in its recent case against Raptim Research. This session will explore how AI is transforming both sides of the regulatory equation, offering practical strategies for managing risk, ensuring trustworthy data practices, and preparing AI-driven scrutiny across FDA-regulated industries.
 
Are you interested in meeting with our experts at this event? Please fill out the form below, and we'll contact you with more details.