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Our SMEs supports in the design and Optimization of formulation.
Facilitate in scale-up, technology transfer, and process performance qualification
Development Strategies & Pathway
Scientific & Technical assistance
Preparation of product development report as per QbD
Setting of quality specifications for drug substance and drug product as per requirements
CMC documentation: Batch Manufacturing Records, Batch Packaging Records, Specifications, Protocols etc.
Formulation development of New Chemical Entities (NCEs)
Support in the pre-formulation, excipient-API compatibility assessment and optimization, physicochemical testing, formulation screening, lab scale formulation and accelerated stability studies to achieve the desired characteristics.
Regulatory Affairs
Quality
Analytical
Packaging & Development
Quality / Regulatory Compliance