New Member Spotlight: Aclairo Pharmaceutical Development Group Inc
Aclairo is a 100% woman-owned small business, comprised of experienced consultants dedicated to providing clear direction and support for development of drugs, biologics and devices. Aclairo is located in Vienna, VA.
Their principals are senior toxicology and regulatory consultants who possess specialized experience as scientists, former FDA team leaders and reviewers, industry strategists, and directors of product development programs.
Aclairo accomplishments include the following: Planned and implemented IND strategies for successful submissions of drugs and biologics; Strategically place products in the appropriate FDA Center to speed development of drugs, biologics, and devices; Successfully authored and submitted scientific justifications and explanations to move drugs from clinical holds and to justify specific Phase IV commitment preclinical testing rather than pre-approval testing; Reviewed literature and minimized the testing submission for 505(b)2 applications; Successfully identified, placed, and monitored nonclinical studies and thus ensured high quality results
For more information visit their website.
