Selvita offer service "CMC analytical support"
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CMC analytical support
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Specifications
- Service Scope: Full-spectrum CMC analytical support including method development and validation, cleaning validation, stability testing, dissolution studies (including TIM1/TINY TIM gastrointestinal models), orthogonal methods development, and impurities identification
- Regulatory Certification: Includes elemental impurities determination aligned to ICH Q3D, along with nitrosamine and pyrrolizidine alkaloid determination and testing.
- Turnaround Time: Leverages state-of-the-art technology and rigorous scientific methodology to support timely delivery of complex CMC analytical programmes.
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