Projects Delivered
Repeat Clients
Years of Experience
Countries Supported
650+ Senior 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 move from concept to market with confidence.
1700+
Satisfied Clients
Vice President Quality and Regulatory Affairs at Werfen Autoimmunity
Working with BioBoston Consulting has been a great experience. They are professional, knowledgeable, and exceeded our expectations. I highly recommend their services.
Vice President, Global Head, Quality Assurance and Data Privacy at Abivax
I had a great experience working with BioBoston Consulting. I used them for consulting with a former FDA inspector. The inspector was professional, knowledgeable and met my expectations. I highly recommend their services.
Associate Director, Quality Systems at Viridian Therapeutics
BioBoston Consulting is a professional, experienced consulting firm of the needs of the hiring manager. It was an absolute delight to work with her because unlike individuals working for other companies that we were also working with she provided experienced relevant candidates to choose from and it was with Bioboston Consulting that we found the excellent resources. Since then she has provided excellent followup and assistance with onboarding and maintaining our hiring needs and relationship with the individuals that we hired through Bioboston Consulting.
Manager QA/RA, PBM at Tem Innovations GmbH (Werfen Patient Blood Management)
We were really satisfied with the service from Bioboston Consulting. The feedback from our colleagues on the internal audit by Alexander Thern was positive. David also received positive feedback from Michelle for the Accriva Audit, regarding Angel’s competence (“very knowledgeable”). Angel also worked independently with Accriva on the audit preparation, which was also very good.
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.
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.
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.
We support you across the full lifecycle: Preclinical, Clinical, and Commercial. This includes early strategy, development and validation, regulatory submissions, inspection readiness, post‑market compliance, and commercialization support.
We support you across the full lifecycle: Preclinical, Clinical, and Commercial. This includes early strategy, development and validation, regulatory submissions, inspection readiness, post‑market compliance, and commercialization support.
We start with a short discovery discussion to understand your objectives, timelines, and constraints. Then we propose a tailored approach, match you with the right experts, and define clear deliverables and milestones before project kickoff.