Where Biotech, Pharma & MEDTECH Teams Go for Proven Results.
We help Pharmaceutical, Biotechnology and Medical Devices companies to advance products faster, eliminate regulatory risks, and operate with certainty, backed by 650+ senior life-science experts, including former FDA investigators.
Our team brings together more than 650+senior consultants including former FDA investigators, quality and regulatory leaders, and clinical and commercial experts dedicated to helping life sciences organizations.
Former FDA Consumer Safety Officer | cGMP Inspection Readiness Expert (Pharma, Biologics, Medical Devices)
Former FDA Consumer Safety Officer with 32 years at FDA (1989–2021), backed by a B.S. in Biology from the University of Arizona and biomanufacturing training through NC State’s BTEC. Stephen supports teams facing high inspection pressure with clear, factual readiness work: mock inspections, cGMP gap assessments, QC lab audits, data integrity checks, and CAPA effectiveness reviews. He also holds FDA investigator and drug/device certification levels.
Former FDA Field Investigator | MedTech Regulatory & Quality Compliance Expert (QMSR/QSR, ISO 13485, MDR/MDSAP)
Former FDA Field Investigator and Medical Device Specialist with 13 years in FDA field investigations and 30+ years in regulatory and quality work. Lori holds a B.S. in Chemistry from Xavier University and maintains highly trusted credentials including RAC/US (RAPS), ASQ CQA, ISO 13485 lead auditor training, and training in MDSAP and EU MDR auditing. She helps medical device and IVD teams build a QMS that is simple, scalable, and defensible, with strength in design controls, risk management, CAPA, supplier controls, and inspection readiness.
Quality Systems & Compliance Expert (Medical Device, IVD, Therapeutic; FDA/ISO)
Quality systems leader with 30+ years of hands-on experience building and remediating FDA/ISO-aligned QMS for growth-stage teams. Andrew holds a B.S. in Mechanical Engineering from Wentworth Institute of Technology and is an ISO 13485:2016 Certified Lead Auditor, with long-standing ASQ senior membership (since 1992). He supports QMS implementation and stabilization across risk management, validation, design controls, supplier quality, document control, and post-market processes.
Clinical Laboratory Director & Diagnostic Quality Systems Expert (CLIA, FDA, ISO; LDT/IVD)
Board-certified high complexity CLIA Laboratory Director with 40+ years in clinical laboratory leadership and diagnostics. Gordon holds a PhD in Pharmacology from Boston University and a B.S. in Zoology from the University of Massachusetts Amherst, and he maintains NRCC Clinical Chemist board certification (through 2027) plus a New York Certificate of Qualification. He has contributed to multiple FDA-cleared 510(k) assays and brings deep experience in LDT development, method validation, QC systems, and QMS buildout in CLIA/FDA/ISO environments.
What makes BioBoston Consulting different from other consulting firms?
BioBoston Consulting offers a one-stop solution for life sciences companies, guiding innovations from preclinical research to commercialization. We combine 650+ global industry experts with a lean structure, delivering tailored support.
Which industries does BioBoston Consulting serve?
We specialize in Pharmaceuticals, Biotechnology, and Medical Devices.
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