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Title: B&H Consulting Services, Inc.
Description: B&H Consulting Services, Inc. is committed to assisting health sciences companies effectively meet their global Regulatory Affairs and Quality Assurance objectives within established deadlines.
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FDA regulations, 21 CRF, Health Sciences Industry, Facility AuditsGMP Audits, Good Manufacturing Practice, Orphan Drugs, Pharmaceutical regulatory protocol amendments, Pharmaceutical regulatory information amendment, Pharmaceutical regulatory Safety Reports, PSUR, Periodic Safety Update Report preparation, Pre-IND Briefing, Pre-NDA Briefing, Clinical Study Protocols, Clinical Study Reports, SOP, Standard Operating Procedures, Analytical Methods, Drug Master File, DMF, Labeling, Core Data Sheet, Environmental Assessment, Drug Product Listings, Drug Establishment Registration, FDA Database, Sterilization Validation Medical Writing, GMP, Documentum-based system, Core Dossier, B&H Consulting Services, B&H, B&H Consulting(View Less)