Aclairo® Pharmaceutical Development Group, Inc. was founded in 2004 with a mission to deliver independent and objective nonclinical and regulatory advice to the pharmaceutical industry. The managing consultants, Hilary Sheevers and Susan Wilson, have extensive experience working for the FDA and all-sizes of pharma. They started Aclairo to provide top-notch advice in the nonclinical and regulatory niches. Since its inception, Aclairo has grown to include many full-time employees who reflect Hilary and Susan’s values of high quality consultation and support. Aclairo 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, pharmacology, 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 11 years, Aclairo has:
- Planned, implemented, wrote and/or strategized IND/NDA strategies for hundreds (yes, this is correct!) of successful submissions of drugs and biologics
- Successfully authored and submitted many dozens of scientific justifications and explanations to move FDA regulated products forward in development
- 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
- Supported dozens of FDA IND/amendment submissions, including orphan drug designations, legacy INDs, and eCTDS
- Planned and help implement Phase 1 studies and wrote/reviewed clinical pharmacology reports
- Written GLP TK/PK reports