BioBoston Consulting

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for Life Sciences

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At BioBoston Consulting

We specialize in guiding your pharmaceutical and medical device products through every stage of development. We offer end-to-end solutions from preclinical research, regulatory strategy, clinical trials, and market entry support, ensuring a streamlined path from concept to market.  

Pre-Clinical

Clinical

Commercialization

All Stages

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Your Journey With Us 

We support you from preclinical to market approval 

At every step of your journey, from preclinical to market approval, we’re dedicated to supporting you. We prioritize your needs and are committed to turning your vision into reality. Let us help you navigate the complexities of drug and medical device development, ensuring your innovations achieve the success they deserve.   

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QUALIFIED CONSULTANTS
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YEAR EXPERIENCE
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MARKET APPROVALS
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Master Control
UniPoint
BioBoston Consulting provided invaluable regulatory expertise, guiding us through FDA fast-track and priority voucher designations. We appreciate their dedication and knowledge. I highly recommend BioBoston Consulting for regulatory support.
Peter PushkoPresident and Chief Scientific Officer at Medigen
Laura Martin is a professional, experienced recruiter knowledgeable 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 because of Laura. Since then, she has provided excellent follow-up and assistance with onboarding and maintaining our hiring needs and relationship with the individuals that we hired through Bioboston Consulting.
Ginny GutierrezAssociate Director, Quality Systems at Viridian Therapeutics
Working with BioBoston Consulting has been a great experience. They are professional, knowledgeable, and exceeded our expectations. I highly recommend their services.
Àngels RomaVice President Quality and Regulatory Affairs at Werfen OEM
I had a great experience working with Laura Martin at 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.
Ana Sharma Vice President, Global Head, Quality Assurance and Data Privacy at Abivax
BioBoston provided timely and professional assistance in the creation and review of quality documents to support our product portfolio. The consultant freed up our staff to focus on high priority tasks.
Jim RichardVice President, Quality & Regulatory at ALPCO
BioBoston Consulting provided invaluable regulatory expertise, guiding us through FDA fast-track and priority voucher designations. We appreciate their dedication and knowledge. I highly recommend BioBoston Consulting for regulatory support.
Peter PushkoPresident and Chief Scientific Officer at Medigen
Laura Martin is a professional, experienced recruiter knowledgeable 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 because of Laura. Since then, she has provided excellent follow-up and assistance with onboarding and maintaining our hiring needs and relationship with the individuals that we hired through Bioboston Consulting.
Ginny GutierrezAssociate Director, Quality Systems at Viridian Therapeutics
BioBoston Consulting provided invaluable regulatory expertise, guiding us through FDA fast-track and priority voucher designations. We appreciate their dedication and knowledge. I highly recommend BioBoston Consulting for regulatory support.
Peter PushkoPresident and Chief Scientific Officer at Medigen
Working with BioBoston Consulting has been a great experience. They are professional, knowledgeable, and exceeded our expectations. I highly recommend their services.
Àngels RomaVice President Quality and Regulatory Affairs at Werfen OEM
I had a great experience working with Laura Martin at 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.
Ana Sharma Vice President, Global Head, Quality Assurance and Data Privacy at Abivax
BioBoston provided timely and professional assistance in the creation and review of quality documents to support our product portfolio. The consultant freed up our staff to focus on high priority tasks.
Jim RichardVice President, Quality & Regulatory at ALPCO
BioBoston Consulting provided invaluable regulatory expertise, guiding us through FDA fast-track and priority voucher designations. We appreciate their dedication and knowledge. I highly recommend BioBoston Consulting for regulatory support.
Peter PushkoPresident and Chief Scientific Officer at Medigen
Working with BioBoston Consulting has been a great experience. They are professional, knowledgeable, and exceeded our expectations. I highly recommend their services.
Àngels RomaVice President Quality and Regulatory Affairs at Werfen OEM

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Insights

At BioBoston Consulting, we believe that informed decision-making is crucial for successful drug and device development. Here are key insights that can guide your journey  

April 2, 2025

Understanding UDI Regulations and Compliance for…

April 2, 2025

Navigating the 510(k) Submission Process for…

April 2, 2025

US FDA Requirements for Design Verification…

April 2, 2025

Ensuring Safe Medical Devices Through Effective…

All insights

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PreClinical
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