We offer a broad range of process and analytical services. We are able to provide such services for all stages of product development. In addition,  we have a solid track record in upgrading and improving existing formulations and analytical methodologies.

Services offered:

i. Analytical Development

• Analytical Method Development & Validation
• Cleaning Residuals Validation
• Dissolution and Drug Release Profile
• Stability Monitoring

ii. Pre-formulation

• Physical Properties
• Powder Characterization
• Forced Degradation Studies
• Compatibility Studies

iii. Formulation Development

• Prototype Formulation
• Preliminary Process Development 

 
iv. Clinical Trial Manufacturing & Scale-up

• Process Optimization
• Scaling up
• Clinical Trial Manufacturing
• Commercial Product Manufacturing & Process Validation

v. Stability studies

• ICH conditions
• Studies & Reporting 

vi. Registration support

• Validation Protocols & Reports
• Documentation Support
• CTD writing
• Registration Strategy Development