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BIOBOSTON CONSULTING
BioBoston Consulting, headquartered in Boston, is a Life Science consulting firm that provides strategic regulatory, quality, clinical and organizational support to pharmaceutical, biotechnology, and medical device organizations from the early stages of product development through to commercialization.
Specialties:
QMS Implementation, Quality Assurance & Regulatory Compliance, Inspection Readiness, Gap Assessment & Remediation, Internal Audits, Supplier Audits, Supplier Management, Qualification & Validation, Regulatory Affairs, Clinical Affairs, Technology Transfer, Risk Management, Project Management, Training, CSV, Clinical Trials, Regulatory Submissions, IND/IDE/NDA/BLA/PMA, IVDR, MDSAP, FDA Inspection Readiness, CMO and CRO Management, and Mock FDA Inspection
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