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Our Services

BioPhia is the strategic partner you need to help you meet milestones and drive your projects to completion while optimizing resources. We offer services as technical experts in product design, development, characterization, validation, manufacturing, and regulatory requirements. We work with you to design and execute a custom plan leading to success.

PRODUCT DEVELOPMENT

Product Development Requirements & Strategies
Product Characterization Strategies
Product Development Process - Formulation, Analytical Method Development & Validation and Stability Testing
Container Compatibility and Materials Characterization
Extractables & Leachables, Biocompatibility Testing and Technology
Particulate Characterization and Strategy
Manufacturing Process Development and Validation
Regulatory Testing Strategy and Requirements
Technology Transfer (R&D to Mfg. Site and Site to Site
Clinical Strategy IND/IDE

PRODUCT REMEDIATION

Product Recall and Remediation Strategies
Manufacturing Process Improvements/Scale-up
Resolution of Manufacturing Issues
Analytical Methods Improvements/Remediation
Product Complaints and Investigations

CHEMISTRY & MANUFACTURING CONTROLS

Due Diligence Activities
Product Development Plan Review/ Risk Assessment
Intermediary for Proprietary Information
Technical/Grant Writing
Quality by Design
Expert Witness

See Our Team

Meet our team of experts who can assist in addressing your challenges.

Contact! Us!