Welcome to Mercurie Consulting
Mercurie Consulting provides regulatory consulting services for radioactive medical products. Marie Curie, a dual Nobel Peace Prize-winning physicist who devoted her life to improving health through her discoveries, is the inspiration behind the business. Mercurie Consulting offers clients radiation safety and policy expertise and access to a network of health physicists, physicians, and regulatory contacts across the U.S.
Services
- Regulatory strategy and analysis to drive business decisions
- Technical support and advisory services for radiation safety programs
- Radiation safety expertise for product research, development, design, and testing
- Regulatory submissions including new radioactive materials license applications, license amendments, and sealed source and device registry certificates
- Liaison work with state and federal regulators, including the U.S. Nuclear Regulatory Commission, Agreement States, and the U.S. Food and Drug Administration
- Regulatory and compliance policy and procedure development and implementation
- Curriculum development and onsite or online training
- Radioactive materials audits and inspection support
About
Ashley Cockerham is the founder and owner of Mercurie Consulting. She worked as a health physicist for the U.S. Nuclear Regulatory Commission for more than 10 years before venturing into private industry. Ashley gained broad experience serving in numerous roles in Medical Affairs, Marketing, Regulatory Affairs, and Compliance with a global life-sciences company that manufactures and sells radioactive microspheres. She graduated from Texas A&M University with a Bachelor of Science in Radiological Health Engineering and holds a Master of Science in Jurisprudence with a concentration in Pharmaceutical and Device Law and Compliance from Seton Hall University School of Law.
Selected Works
Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses, Final Report
NUREG-1556, Volume 9, Revision 3
Team lead and contributing author of technical report that provides program-specific guidance and assists individuals in preparing applications for materials licenses for the medical use of byproduct material.
Yttrium-90 Microsphere Brachytherapy Sources and Devices, TheraSphere™ and SIR-Spheres® Licensing Guidance
Team lead and primary author of licensing guidance issued between September 2007 and February 2016 for yttrium-90 microsphere brachytherapy for the treatment of liver cancer.
Radium-223 Dichloride Medical Use Licensing Memorandum
Federal staff member responsible for evaluating the radiation safety aspects of radium-223 dichloride, now known as Xofigo, and issuing the medical use licensing decision for regulation as unsealed byproduct material under Title 10, Code of Federal Regulations, Part 35.
Written Directives for Y-90 Microspheres
The information required in written directives for yttrium-90 microsphere brachytherapy changed significantly as product use increased after initial therapy adoption in the early 2000’s. This presentation provides an overview of the changes in written directive requirements from 2002 to 2016 and an analysis on reported medical events for each type of yttrium-90 microsphere brachytherapy.
Authorized Users for Y-90 Microspheres
Physician training and experience requirements for yttrium-90 microsphere brachytherapy changed significantly as interventional radiologists took the lead to administer the therapy as Authorized Users. This presentation provides an overview of the changes in guidance from 2002 to 2016 with a focus on training and experience requirements for interventional radiologists.
Emerging Thorium-227 Radiotherapy
Targeted thorium conjugates are being developed and evaluated based on their alpha-emitting properties for treatment of breast, gastric, prostate, lung, ovarian, pancreatic, and many other types of cancers. This presentation provides an overview of Th-227-based radiopharmaceuticals, which have the potential to become effective new cancer therapies.
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