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

Regulatory Affairs