About Us
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.
Projects Delivered
Repeat Clients
Years of Experience
Countries Supported
650+ Senior Experts, including former FDA investigators
About Us
Where Biotech & Pharma 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 350+ senior life-science experts, including former FDA investigators.
Why Companies Choose BioBoston Consulting

Senior Expertise
650+ Senior global industry experts, 20+ years of experience, and 1000+ successful projects delivered.

Solutions built
From preclinical research to market entry, we understand the pressures your team faces and deliver tailored guidance every step of the way.

one-stop solution
Preclinical, clinical, commercialization, all stages covered under one roof.

cost-effective support
High-end expertise and exceptional outcomes, minus the high-end price tag.

expert guidance
Direct support from senior consultants, ensuring actionable insights when you need them most.
Why Companies Choose BioBoston Consulting
Senior Expertise you can trust
350+ Senior global industry experts, 20+ years of experience, and 50+ successful market approvals.
Solutions built around your world
From preclinical research to market entry, we understand the pressures your team faces and deliver tailored guidance every step of the way.
Comprehensive, one-stop solution
Preclinical, clinical, commercialization, all stages covered under one roof.
Flexible, cost-effective support
High-end expertise and exceptional outcomes, minus the high-end price tag.
Immediate access to expert guidance
Direct support from senior consultants, ensuring actionable insights when you need them most.
Meet Our Experts
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 move from concept to market with confidence.
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.
Executive Director | Global Quality & Regulatory Strategy Expert (Pharma, Biotech, Medical Devices)
Devices)Quality and regulatory leader with 20+ years in regulated life sciences and international experience across Europe, the United States, and Canada. Laura oversees a global bench of 650+ senior consultants, including former FDA investigators, enabling rapid access to specialized expertise. She supports programs from early development through clinical and commercial stages, including post-market oversight, using a practical, risk-based approach. Her scope includes QMS buildout and remediation for early-stage companies and enterprise, multi-site quality systems with inter-site governance across North America, South America, Europe, and Asia, linking regulatory strategy, quality system design, and operational execution to support inspection readiness and scalable operations.
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.
Stephen D. Brown
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Lori A. Carr
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Andrew D. Connerty
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Gordon C. Siek
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Laura M.
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Our 3 Steps Approach
Tell us your challenge
01
discovery/intake
Get matched with the right experts
02
matching the right expert/team
Execution & Delivery
03
execution, delivery, and follow-through
Our 3 Steps Approach
Step 1
Tell us your challenge
30 minutes meeting to understand your goals, timelines, and requirements.
Step 2
Get matched with the right experts
Direct support from senior consultants, ensuring actionable insights when you need them most.
Step 3
Execution & Delivery
Our senior consultants drive your project forward to deliver fast, actionable results.
Frequently Asked Questions
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.
We specialize in Pharmaceuticals, Biotechnology, and Medical Devices.