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Consulting Services to the
Pharmaceutical and Diagnostics
Industries
About Us
Over 30 years in the Pharmaceutical and Diagnostics industries, initially in drug development and with the advent of companion diagnostics, in the co-development of drugs with their associated assays which are are the cornerstones of precision medicine.
With a background that includes clinical development, regulatory affairs, project and program management, medical writing, etc. for both pharmaceuticals and diagnostics, we advise both established and emerging companies on their clinical and regulatory strategies (US EU/UK/ROW) for registration and beyond. Experience with a variety of diagnostics including IVDs/CDx, LDTs, combination products, SaMD, etc.
Recomendations
Dr. Engel has 30+ years of Rx & Dx co-development regulatory experience-there is no one in the industry with more hands-on experience. I reported to Dr. Engel in 2014 when I was a regulatory affairs manager at Roche/Ventana. We worked on multiple immunotherapy companion diagnostics projects together, and she taught me all about the regulatory considerations when taking an IVD from concept/feasibility through the marketing submission (PMA) process. We have kept in touch and have partnered on several consulting projects together, including companion diagnostics (blood & tissue-based) and a solid tumor MRD assay. I highly recommend Julie as a consultant; she will always identify potential regulatory & technical risks that the team has not thought of. This is why she is an important member of Boudicca Dx. regulatory advisory panels; as a mock regulatory reviewer, she prepares the product development teams for any unexpected questions & potential deficiencies during regulatory interactions. I really enjoy working with Julie on client projects and highly recommend her consulting services.
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Dr. Kelly Gordon
Founder @ Boudicca Dx., LLC
Contact
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