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Over 25 Years’ Experience On All Phases Of Drug Product Development, Testing, Regulatory Affairs, Quality Control, Quality Assurance, Validations And Production – From API Through Finished Products And Vast Experience Working With Pharmaceutical and Third Party Contract Development Testing and Manufacturing Companies in The USA, Italy, France, Switzerland, Germany and Japan
Consulting Services Offered Include, But Not Limited To:
REGULATORY AFFAIRS – CMC
Pre-Submission Review of CMC Section of INDs, ANDAs and NDAs – eCTD CMC Module 3
Strategies for Reduction of Late Stage Drug Product Failures
START UP AND SMALL PHARMA AND BIOTECH COMPANIES
Strategies for Speedy Product Development Strategies via Third Party CMOs
Due Diligence Review of Planned Product Acquisitions
THIRD PARTY OUTSOURCED SERVICES
Arrange, Audit & Manage Outsourced Formulation Development; Testing, Method Validations; Production of Finished Products
CLINICAL SUPPLIES
Provision of Fast, Efficient and Cost-Effective Delivery of Clinical Trial Supplies through GMP Compliant Third Parties including Over-encapsulation of commercial products and placebos for blinded studies
TURNKEY PROJECTS
Outline and Costs for the Set-up of Production plants and Testing Laboratories
CONTACT
Aloysius Anaebonam, Ph.D.
breejtech@gmail.com
Principal Consultant
BREEJ Technologies, Inc.
Pharma and Biotech Consulting Group
44 Stedman Street, Unit 6, Lowell, MA 01851