BioBoston Consulting | Life Sciences Regulatory, Quality & Clinical Experts

BioBoston Consulting

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650+ Senior Experts, including former FDA investigators 

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REGULATORY SUBMISSIONS IND AUDITS COMPUTER SYSTEM VALIDATION IDE FDA INSPECTION READINESS BLA GAP ASSESSMENT
REGULATORY SUBMISSIONS IND AUDITS COMPUTER SYSTEM VALIDATION IDE FDA INSPECTION READINESS BLA GAP ASSESSMENT

Who We are

We help biotech, pharma & MEDICAL DEVICES teams with on-demand senior experts

650+ senior experts including former FDA investigators, quality and regulatory leaders, and clinical and commercial experts dedicated to helping life sciences organizations.

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Customer testimonials

    Àngels Roma

    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.

      Ana Sharma

      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.

        Ginny Gutierrez

        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.

          Marianne Brill

          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.

            George Sgourdas

            Sr. Manager Quality Systems at Werfen Hemostasis and Blood Gas Reagents

            I am a Quality Assurance professional with Werfen. I contacted BioBoston Consulting to inquire about the availability of a former FDA investigator to conduct an internal audit of the quality system. BioBoston Consulting responded immediately to my email, and a meeting was scheduled to discuss the scope of the audit. The meeting included the person who performed the audit and the logistics were finalized. The audit was performed as scheduled, and the auditor provided useful information and feedback. The audit report was comprehensive and provided by the due date. My overall experience with BioBoston Consulting was positive, and I would use them for future audits.

              Grace Choi

              CEO and Founder at Larabee

              The BioBoston team is an absolute pleasure to work with. They handled our compliance needs with speed, efficiency, and so much clarity. We're looking forward to working with them again!

                Emma Halter

                Quality Assurance Manager at True Indicating

                BioBoston gave insight on what we may expect an audit from the FDA would resemble.

                As a result of the audit, clarification within procedures was improved for easy interpretation from any auditor perspective.

                I would recommend BioBoston because it was helpful in receiving input from a prior FDA auditor. At the time we had yet to be inspected from the FDA and sought feedback from a qualified individual and BioBoston achieved that.

                  Manibarsha Goswami

                  Global Product Sustainability Sr. Manager at Werfen Hemostasis and Acute Care Diagnostics

                  BioBoston quickly connected us with highly experienced and knowledgeable consultants. Our program required someone who could rapidly integrate into the team, understand the process, and deliver results. BioBoston provided this support with impressive flexibility. Our main goal was to establish a clear process for product compliance while also influencing and educating the broader organization. We have made meaningful progress along this journey. I would absolutely recommend BioBoston Consulting, working with their team has been a great experience. You can consistently expect high‑quality candidates in a short timeframe, and collaborating with BioBoston Consulting’s team has been excellent.

                    Leon Lambry

                    Senior Director, Quality Assurance and Regulatory Affairs at Werfen Transplant

                    BioBoston, facilitated our cGMP Quality week. The organization performed virtual live training on topics such as FDA QSR, MDSAP Production and process control, and Implementation of 5s. General understanding of the regulations drastically improved. We are a manufacturing site with a large number of employees with less than 3 years experience working in a cGMP environment. The training vastly helped with bridging the knowledge gap for this group of newcomers. I would recommend BioBoston and would use them again for training at our site.

                      Gregory C. Mattson

                      Director, Global QARA Services and Product Sustainability at Werfen Hemostasis and Acute Care Diagnostics

                      Bioboston helped my department with the following:

                      Website Labeling and Documentation - Bioboston provided a Document Administrator who helped us with investigating and creating a process to adequately manage our website labeling and documentation for compliance. This also included correcting 100's of website labels and documents so that they would appear correctly on the website.

                      Product Sustainability Steward - Bioboston provided a Corporate Product Steward who helped us establish a corporate product sustainability program. This included scoping our business, products and countries along with assessing regulations, policy's and procedures and providing training and guidance.

                      FDA Mock Inspections - Bioboston provided prior FDA Inspectors to help prepare multiple sites within Werfen to ensure they are FDA Inspection ready.

                      As a result, compliance to regional and country regulations that require product labels and documentation on our Website was improved. As well as compliance to regional and country product sustainability regulations and FDA Inspection readiness. I would recommend Bioboston. The talent provided by Bioboston significantly helped us to improve, learn and grow as an organization. I enjoyed working with everyone.

                        Eddie Morrissey

                        Director of Quality at Werfen Hemostasis and Acute Care Diagnostics

                        BioBoston Consulting helped our organization with Internal Audits. As a result, FDA audit preparedness was improved. I would recommend them based on their Experienced Consultants.

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                        Meet Our Experts

                        About Us

                        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.

                        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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                        TRUSTED PARNERS ACROSS PHARMA, BIOTECH AND MEDTECH

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                        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.

                        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.

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                        Take the Pressure Off, Our Experts Are Here to Help

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