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 Mr. Little joins Aclairo ® as a Consultant in Regulatory Affairs and Compliance with over 11 years experience in preclinical drug development and regulatory affairs. Previously a Regulatory Affairs Manager with Aeris Therapeutics (Woburn, MA), Mr. Little managed regulatory submission planning in conjunction with project-based development teams, provided strategic preclinical planning, qualified CRO facilities, monitored all contracted studies and reviewed all preclinical study reports. Additionally, he oversaw the transition from paper to electronic submissions for a combination product according to the eCTD specification. Mr. Little has experience preparing and submitting pre-IND packages, INDs, NDAs, CTDs, eCTDs and other regulatory documents. Mr. Little is also RAC (US) certified with knowledge of current regulations. Mr. Little’s preclinical drug development expertise includes general toxicology, reproductive toxicology and ADME study design, data analysis and reporting, GLP compliance and CRO monitoring. |
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