We offer a breadth of expertise and research experience, and have been involved in the design and evaluation of over one hundred Phase 1 studies, including more than 50 abuse liability studies, as well as first-in-man, pharmacokinetic, drug/alcohol interaction and proof of concept studies. We have experience in multiple therapeutic areas, such as addiction, pain, epilepsy, obesity, anxiety, depression, ADHD, and neurodegenerative disorders. Our expertise in abuse liability has led to invitations to present at meetings with FDA involvement, which have helped shape the regulatory landscape in this evolving area of research. Our services include scientific consulting in abuse liability and abuse deterrence, clinical pharmacology and early phase drug development, and regulatory strategy.

Abuse Liability and Abuse Deterrence

We provide scientific, regulatory and operational input on abuse liability assessments for new chemical entities (NCE) and abuse-deterrent formulations (ADF). We can help you at all premarket stages of program or study development, from initial planning up until the regulatory submission.

Clinical Pharmacology and Early Phase Drug Development

We provide advanced input on Phase 1 study design and drug development programs, particularly for CNS drugs.

Additional Services

Contact us for more information about our services