Our Story
Advance BioReg Inc. (ABR), based in Ohio, was originally founded in 1998 as T. Leland Seeger & Associates Inc. (TLS) to provide product-specific regulatory, compliance, and clinical advice and strategy in the early stages of product development. For 25 years, TLS worked with medical device, drug, and biological product developers to obtain marketing approval for their products in a timely and cost-effective manner. In 2023, TLS was rebranded as Advance BioReg to more accurately reflect the company’s comprehensive portfolio of compliance and regulatory capabilities.
Today, Advance BioReg is a consulting firm leveraging our years of experience to help clients navigate the labyrinths of new product development and quality control. We serve developers and manufacturers of medical devices, in vitro diagnostic products, and drug and biological products, as well as over-the-counter medical devices, drug products, and nutrition products. With a streamlined, customer-centric approach and extensive knowledge of the regulatory requirements for these industries, we work tirelessly to achieve successful results for our clients, large and small.
OUR MISSION
Our mission is to deliver both strategic advice and targeted, tactical support to our clients throughout the entire product life cycle.
Our Leadership
Advance BioReg’s executive team combines deep industry expertise with extensive operational and regulatory experience to provide our clients with the support they need during every stage of their product’s life cycle.
Trudie L. Seeger, Ph.D.
Chief Executive Officer
Trudie L. Seeger, Ph.D. has over 30 years of experience in the pharmaceutical, biologics, and medical device industries. Her combination of scientific knowledge and regulatory affairs expertise is the guiding principle behind ABR’s comprehensive program of services. Dr. Seeger has earned industry-wide recognition for successful hands-on leadership of clinical development programs, comprehensive quality and compliance improvement programs, and successful regulatory submissions.
Dr. Seeger earned her doctorate in experimental pathology from the State University of New York and performed post-doctoral research in clinical immunology. Her pharmaceutical management background includes eight years at Bristol-Meyers and Schering-Plough and 8 years at an Ohio biotechnology company, Neoprobe Corporation, where she was a Vice President, Regulatory Affairs, overseeing R&D, Clinical, and Regulatory Affairs.
Dr. Seeger leads ABR's team and company direction, and is directly involved in delivering strategic, technical, and compliance services to ABR's clients.
Alicia A. Rice
Chief Operations Officer
Alicia A. Rice, RAC-Devices, has more than 30 years of industry experience including Medical Device operations management and extensive experience in the assessment, development, and deployment of new processes. She has a Bachelor of Industrial Engineering degree from Georgia Institute of Technology, which, along with her industry experience, uniquely qualifies her to evaluate and implement quality-compliant, lean, and sustainable processes.
She has broad industry experience across multiple Fortune 500 firms, including Baxter Healthcare, Johnson & Johnson, and Abbott Laboratories. This experience includes projects related to process validation, packaging and labeling operations, software methodology development and assessment, CAPA process development and assessment, plastic molding and extrusion operations, and internal and external auditing - a diverse background that brings a holistic approach to every client project. ABR relies on Alicia to leverage her operational background in empowering our clients to meet their compliance and regulatory objectives – on time and within budget.
Andrea Milonas
Office Manager
Andrea Milonas holds a BS in Business Administration and has over 20 years of experience managing enterprise-wide projects in regulatory compliance, human services, and the healthcare industries. She is an expert in the accounting and management practices essential for supporting small- to large-scale client projects, ensuring accurate estimates, tracking to defined budgets, and accountability for finances, deliverables, and milestones.
At Advance BioReg, Inc. (ABR), and previously at ABR’s sister firm, AccuReg, Inc. (ACR), Andrea has been responsible for the coordination and management of all active client projects and prospective client communications, including coordination of all project proposals, Statements of Work, and RFP responses. She often is the first responder to any prospective client’s request for information and is the essential go-to resource for ABR’s clients while projects are in progress.
Our Team
It’s a simple concept: To get the job done right, pick the right person for the job. The ABR team brings extensive industry knowledge to the table for every client and every project. Unlike firms in which the expertise is concentrated in the management team only, ABR ensures that every team member has the right experience and credentials to serve the needs of each client assignment.
ASSOCIATES
ABR’s team of professional Associates are driven by a hands-on work ethic honed through years of industry experience. Our Associates' backgrounds include:
• Quality Systems
• Regulatory Affairs
• Clinical Research
• R & D
• Manufacturing
• Process Engineering
• Aseptic Processing
• Sterile Processing
• QA/QC
• Analytical Chemistry
• Immunochemistry
• Microbiology
• Statistical Analysis
• Technical Writing
• Software Systems
Collectively, our Associates have worked across the full range of medical products, from novel pharmaceuticals, parenterals, and sustained release dosage forms, to sunscreens and other OTC formulations; from Class I Exempt to Class III devices; from simple to complex IVDs; and from low- to high-risk software.
AFFILIATE ASSOCIATES
In addition to our in-house staff, ABR maintains a vast network of highly qualified Affiliate Associates. These individuals supplement our core team with additional experience and specialized expertise, allowing us to effectively serve clients with extensive or long-term projects at various locations in and out of the U.S. All of our Affiliates meet the high standards for credentials and experience required of our in-house Associates, and their qualifications are tested and proven before any client assignment is made.