About
ATL Regulatory Consulting, LLC is a consulting firm specializing in providing Regulatory Affairs and Compliance services to the pharmaceutical industry. Our holistic approach helps companies successfully navigate the complicated pathway to drug product approval and ongoing site compliance. We provide firms with Regulatory Affairs strategic planning and overall management of drug product submissions to the FDA. We support all aspects of regulatory and compliance requirements from the initial submission of filings, through to approval and post-approval submission activities. Additional focus is placed on helping companies obtain FDA facility approvals and maintain strong quality systems. We are an active partner in the management of projects from the initial planning stage through post approval product changes.
ATL Regulatory Consulting was founded by Anne Toland who has over 25 years of pharmaceutical experience. Anne has a demonstrated knowledge of regulations and the NDA/ANDA submission process with a successful track record in obtaining drug product approvals. She has proven expertise in working effectively with the FDA, broad experience in handling PAI and GMP inspections and experience in Project Management and Regulatory Strategy.
Our team consists of contributing consultants who are experienced in a broad array of pharmaceutical support systems including all aspects of Regulatory Affairs, Compliance, GMP and Quality Systems auditing, SOP Development, Training and Remediation plans.