Aclairo History
Founded in 2004 by ex-FDA regulators, Aclairo PDG is committed to delivering independent and objective advice and guidance to the pharmaceutical industry in the areas of nonclinical pharmacology, toxicology, DMPK, and clinical pharmacology. Our consultants, composed of former FDA supervisors/reviewers and industry veterans, have over 350 years of combined drug development experience. Aclairo is a wholly owned subsidiary of Experimental Pathology Laboratories, a private, employee-owned company which has become industry and government’s premier source for expert toxicologic pathology evaluation and consultation.
2004
Founded by former FDA reviewers
Aclairo® Pharmaceutical Development Group, Inc. was founded in 2004 by former FDA reviewers with a mission to deliver independent and objective nonclinical and regulatory advice to the pharmaceutical industry. Aclairo was started 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 these values of high quality consultation and support.
2012
Expansion into clinical pharmacology and nonclinical ADME/DMPK
In 2012 Aclairo’s services expanded to include clinical pharmacology and nonclinical ADME/DMPK consultation. The DMPK/TK group at Aclairo now supports studies, ADME strategies for large and small molecule therapies, and clinical pharmacology for early phase trials.
2016
Cell & Gene Therapy group established
In 2016, Aclairo’s Cell and Gene Therapy group got its start. The CGT group at Aclairo now supports all nonclinical aspects of CBER-regulated programs, including viral and non-viral gene therapies, gene editing, xenotransplantation, and genetically engineered cell therapies.
2018
Acquisition by Experimental Pathology Laboratories (EPL)
In 2018, Aclairo was acquired by Experimental Pathology Laboratories, allowing Aclairo consultants to have access to all of EPL’s specialized pathology services and providing EPL clients with strategic advice from Aclairo.
2020
A fully virtual company
In 2020, Aclairo became a virtual company, with all staff working remotely. This flexibility allows Aclairo to attract the best consultants from across the country and provide advice in many time zones.
2025
Aclairo expanded its model informed drug development capabilities through the integration of population pharmacokinetic, physiology modeling and in vitro/in vivo approaches to its standard NCA or compartmental modeling services enhancing its exposure/response assessments for small molecules and biologics in both preclinical and clinical applications.
Aclairo continues to hire the best and the brightest from the FDA and industry. 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. Aclairo’s superior knowledge and experience with the pharmaceutical development process have allowed us to assist our clients in ways no other consultancy can.