Aclairo® Pharmaceutical Development Group, Inc. was founded in 2004 by Dana Dunn, Hilary Sheevers and Susan Wilson with a mission to deliver independent and objective nonclinical and regulatory advice to the pharmaceutical industry. The founders, having extensive experience working for the FDA and nonclinical CROs, started Aclairo to provide top-notch advice in the nonclinical and regulatory niches. Since its inception, Aclairo has grown from 4 to 17 employees and continues to hire the best and the brightest from the FDA and industry. In addition to our core niches of nonclinical and regulatory, we now offer clinical ADME/DMPK consultation. All of Aclairo’s employees possess specialized knowledge and experience in various pharmaceutical arenas such as regulatory strategy and oversight, toxicology, DMPK, and overall program design, placement, management and interpretation. Our offices are conveniently located in the Washington, DC metro area, not far from FDA.

Aclairo’s superior knowledge and experience with the pharmaceutical development process have allowed us to assist our clients in ways no other consultancy can.

In the past 7 years, Aclairo has:

• Planned and implemented IND/NDA strategies for successful submissions of drugs and biologics
• Strategically placed products in the appropriate FDA Center to speed development of clients’ devices, biologics and/or drugs
• Successfully authored and submitted scientific justifications and explanations to move FDA regulated products from clinical holds
• Reviewed literature and minimized the testing requirements for 505(b)(2) applications
• Performed site identifications, placement, and monitoring of nonclinical studies to ensure high quality results