Jennifer Ahearn – Owner/Ceo

Ms. Ahearn specializes in FDA regulated product compliance. She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations relating to FDA regulated product quality and manufacturing. Ms. Ahearn has assisted pharmaceutical, medical device and dietary supplement companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms, medical devices and dietary supplements.

Dan Spankie – Principal Consultant

Mr. Daniel Spankie specializes in pharmaceutical and medical device regulatory compliance and has over 19 years of experience in the fields of quality control, chmistry, regulatory compliance, analytical method development, data integrity, and validation. he has successfully managed large quality organizations through warning letter and site remediation projects. In his role as Informatics Specialists, he helped design and implement Chromatography Data Systems (CDS), Scientific Data Management Systems (SDMS), and Labratory Information Management Systems (LIMS) for both site based and global cGxP networks. He has extensive background in auditing and remediation of data integrity issues and has developed certification programs for data reviewers in regulated environments. Mr. Spankie focuses on providing compliant, robust, and efficient solutions and processes for validation programs, laboratory and manufacturing audits, and data integrity audits and training.