Established in 2024, AO Regulatory Consulting, LLC is a boutique regulatory firm committed to translating health authorities such as the FDA and EMA for our pharmaceutical and drug clients, to help them navigate complex regulatory landscapes.
AO stands for Alpha and Omega, beginning to end.* Regulatory considerations affect product development from the beginning. The earlier you invite a regulatory strategist to the table, the better your chance of getting to the end – a product marketing application. There are many aspects of regulatory affairs that contribute to a product development program. Often, as a company grows, regulatory services are added piecemeal with different providers. Let AO Regulatory Consulting be your beginning to end solution and keep you on the path to regulatory success.
Owner and Principal Consultant
Alicia Staz, M.S., RAC has over 25 years’ experience in the pharmaceutical industry. She started her career at a large pharmaceutical company in Vaccine Development where she worked on several vaccines licensed by FDA including RotaShield and FluMist. After 14 years in Research & Development and Quality, she obtained a Master’s Degree in International Regulatory Affairs from Northeastern University and transitioned from Quality to Regulatory Affairs. Now her sole focus is to develop and execute regulatory strategies that bridge the gap between Sponsors and health authorities (HA) and bring much-needed therapies to patients.
She has a comprehensive understanding of US FDA and EMA regulations and ICH guidance with the ability to develop and execute effective regulatory strategy. Her broad experience across drug development has given her a multifaceted, end-to-end understanding, having spent significant time in the analytical lab, the manufacturing suite, Quality, and Regulatory Affairs. She is highly experienced in the development and submission of original IND/CTA and amendments, preparation for and execution of HA meetings (Pre-IND, Type A/B/C, End-of-Phase, and Scientific Advice), orphan drug designation requests, pediatric study plans, and expedited access requests (accelerated approval, fast track, breakthrough therapy designation, and regenerative medicine advanced therapy).
She is efficient, organized, and able to oversee multiple complex projects in a high-energy environment with impeccable attention to detail. Because she has overseen Regulatory Affairs at several organizations, she can come in and hit the ground running. No direction is needed (except to your document repository!) – she will begin generating results immediately. She clearly and confidently communicates risks and benefits associated with regulatory decision-making to allow informed business decisions to be made at the executive level.
Connect with her on LinkedIn.
*Revelation 22:8, “I am the Alpha and Omega – the beginning and the end,” says the Lord God. “I am the One who is, who always was, and who is still to come – the Almighty One.”