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CMC DEVELOPMENT

CMC Consulting for NCEs, Generics and Branded-Generics (505B2s): 

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  • Formulation design & development

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  • Stage-gated Product development to maximize success

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  • Integrating PK-PD, IP and formulations sciences in rationale Product development

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  • Preclinical Phase 1 to NDA filing

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  • Dosage Forms: Oral solids,   Injectables, Nasal delivery, Sub-lingual delivery and specialized formulations for Pediatrics & Geriatrics​

Scale-up & Tech-transfers:

  • Quality-by-design​

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  • Trouble-shooting and scale-up challenges​

Life-cycle Management:

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  • Generics & Branded-generics (Innovative-generics) development​

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  • Product development & trouble-shooting for NCEs

Phone: +1 (416) 508 2061

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LinkedIn:

©2024 by Credence Pharmaceutical Consulting

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