Nora is a Quality and Compliance Professional with more than 20 years of experience from the nations’ leading biotechnology, medical device, and pharmaceutical organizations including Biogen and Stryker Corporation. She has been called upon to manage the quality and compliance for companies at the forefront of discovery and development of novel cancer drugs and small-molecule medicines to fight difficult-to-treat cancers. Her reputation for excellence is the result of her extensive experience in GxP Quality Management Systems, QC processes for clinical study document management, and globalization procedures in the life science industries. She has exhaustive knowledge of international clinical stage readiness regulations and the rigors of filing readiness for the U.S. FDA, the European Union EMA, Japan’s PMDA, and Health Canada.
Nora has built her career working in a wide range of highly specialized departments including Pre-Clinical, Bio-Assay Development, Clinical Pharmacology, Medical Writing, Quality Assurance, and Regulatory Affairs- CMC. She is experienced in leading training programs and ensuring compliance, Post-Marketing Manufacturing Change Control Management, and leading the QC for international Board of Health queries. She is a strong leader committed to the work and brings integrity, organizational skills, and a spirit of collaboration to every task.
Contact us to see how NEB Pharmaceutical Consulting can help your company achieve quality excellence.
Medical Writing Support
NEB Pharmaceutical Consulting is located in the MetroWest Boston area, but we can support clients and their projects globally. Contact us to see how NEB Pharmaceutical Consulting can guide your company to achieve quality excellence.
P.O. Box 5102, Framingham, Massachusetts, United States
Standard USA Business Hours (EST) with International Flexibility
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