Beacon BioPharm Associates LLC
Beacon BioPharm Associates LLC provides our supply chain consulting clients with more than 35 years’ experience in the biopharmaceutical industry, covering small to large companies from both the innovator and vendor perspective. We deliver an in-depth understanding of biopharmaceutical development, commercialization and innovative supply chain strategies.
Processes and Systems
Process Improvement and Optimization
Interactive Response Technology Systems (IRT/IxRS)
Computer System Integration
Deviation and Complaint Management System Support
SOPs – Development, Improvements, and GAP analysis
Analytical Equipment Management
Validation
Strategic Program Management
IMP, Comparator, CoMed, & Ancillary Strategy
Packaging and Global Distribution Strategies
Clinical Protocol Interpretation
Clinical Demand / Supply Plan Development
Vendor Selection and Management
Budgeting, Forecasting, and Financial Tracking
Training Program Development
Audit Support
Clinical Supply Strategy and Execution
Unblinded Clinical Supply Oversight
Packaging, Labeling, Distribution, Returns, Reconciliation, and Destruction
Expiration Date Management
Temperature Excursion Management
Site Documentation Creation
End of Study Documentation Review and Archival
Michelle Friedman, B.S.
Principal Consultant, Co-Founder
Phone: 949-734-0447
Email: Michelle.Friedman@BeaconBioPharm.com
Paul Hingst, B.S. MBA
Principal Consultant, Co-Founder
Phone: 805-651-3981
Email: Paul.Hingst@BeaconBioPharm.com
Clinical Supply Chain Consultants, Pharmaceutical Supply Chain Consultant, BioPharm BioPharma supply chain management, IVRS, Interactive Voice Response Technology, IWRS, Interactive Web Response Technology, IxRS, IXRS, TMF, Trial Master File, Supply chain solutions, deviations, investigations, CAPA, Corrective Action Preventative Action, Import License, CITES permit, Convention on International Trade in Endangered Species, US Fish and Wildlife, FWS, Import, Export