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 Karen Walthall leaves Milestone and joins Aclairo® to continue her consulting career as Associate Director of Regulatory. Ms. Walthall has 7 years experience writing numerous types of regulatory documents including INDs, NDAs, CTDs, pre-INDs, literature reviews, and position papers. Ms. Walthall has successfully taken on the writing and/or managing of 5 CTDs (Module 2, preclinical safety). She recently played a major role in the writing of peer-reviewed journal articles concerning the postnatal development of bone and the gastrointestinal system in humans and animals. Ms. Walthall is an excellent writer, as evidenced by her being authorship or co-authorship on a variety of position papers for industry drug sponsors, including metabolism and PK evaluations, safety evaluations of excipients, and literature reviews to support toxicology submissions. She continues her career with developing expertise in project management as she prepares and manages timelines and staff for regulatory projects and CTD submissions. |
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