Lori MacCausland is Principal Consultant with 40 years life science GxP experience across medical devices, pharmaceuticals, biologics, and combination products. She brings extensive comprehensive regulatory experience across disciplines spanning clinical, nonclinical, pharmacology, biopharmaceutics, labeling, and chemistry, manufacturing, and controls. Lori has provided strategic guidance and led development programs across a broad range of product indications including orthobiologics, neurology, pulmonary, rare and genetic diseases, gynecology, gastroenterology, oncology, inflammatory, ophthalmology, cardiovascular and renal, hematology, psychiatry, infectious diseases, and anesthesia/addiction/pain. Also, she is experienced with quality compliance activities (manufacturing, clinical, development) and requirements in the US and globally (21 CFR 58, 210, 211, 820; ICH; MDR; ISO 13485, and 14971).
Lori’s FDA approvals include a lead role with Ceredase, Carbatrol, Nava Ring, Ceramic Joint Replacement, BD Max, US Boostrix label expansion, and Infanrix Combination Device Syringe. Lori has provided strategic guidance and led medical product development from concept through commercialization and life cycle management. She has experience leading meetings with FDA and Notified Bodies in EU, as well as working with Canadian and Japanese regulatory authorities. In addition to experience authoring INDs and NDAs (eCTD format), she also has experience submitting successful requests for product designation (RFDs), Orphan Designation and Rare Pediatric Disease Designation and negotiated requirements for pediatric study plans and post-approval requirements.
Lori has additionaly prepared Q-submissions, 510(k)s, De Novo, PMA timelines, and 513(g) submissions in the US and global device registrations (EU, Canada, and Asia). Also, she is experienced in executive business operations and program management performing due diligence product reviews, gap analyis, investor meeting budget and timelines, and serving as an IRB advisory board member.
Lori graduated from Northeastern University, Boston, MA with a Master of Science degree. She graduated from the University of Maine with a Bachelor of Science degree. Her business is in the U.S. Eastern Standeard Time zone and accomodates global online schedules. Lori is a member of the Regulatory Affairs Professionals Society (RAPS) and the Digital Medicine Society (DiME).
