Research - Boxford, Massachusetts, United States
Anne Marie Woodland is the founder and principal consulting of WRQ Consulting Services. The company was started in 2021 to provide regulatory affairs and quality assurance consulting services to smaller biopharmaceutical companies for programs that are in early phase development to marketing applications for biologics including gene and cell therapy products. Specialties include creation of CTD, IND, BLA, MAA submissions, agency meeting packages, agency responses, and developing and executing regulatory strategies globally. Demonstrated success in strategic regulatory planning and risk assessment for product and clinical development programs and proven track record in effective leadership through establishment and development of regulatory affairs and quality assurance organizations, by incorporating efficient programs and systems, and mentoring staff to right size and scale for start-up to mid-sized organizations.