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We offer regulatory consulting services for biologics, medical devices and companion diagnostics.
- Regulatory Strategy Development
- GLP consulting, oversight, and compliance
- CRO selection and management
- GLP Audits
- Early-stage development planning assistance
- Clinical Development and CTA negotiation
- Integrated Summary of Immunogenicity (ISI) preparation
- FDA Meeting Preparation & Engagement
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Diagnostic Solution
Diagnostic Solution
Diagnostic Solution
Unleashing the power of Amplatto™ to Point of Care Testing
Antibody Discovery
Diagnostic Solution
Diagnostic Solution
Unique and Proprietary Chicken Monoclonal Antibody Technology
Biosimilar Strategy
Diagnostic Solution
Biosimilar Strategy
As the regulatory landscape continues to evolve for biosimilars, the intriguing challenges . . .