Services

Clinical Phase API - Analytical Laboratory Services

Pharma Solutions offers Analytical laboratory services on a standalone basis from their site in Torcan (Toronto) , UK and Chennai. The sites are equipped with range of HPLCs, LC/MS, GC/MS, NMR required for isolation and characterisation. The analytical laboratory are GLP and the services offered are

Method development, validation and transfer

• Develop analytical methods for testing raw materials, IPCs, intermediates, API and drug product
• Develop stability indicating methods
• Validate analytical methods in accordance with FDA and ICH guidelines
• Formally transfer methods to or from external laboratories as per protocol
• Analytical development for cleaning verification and validation

Stability Studies

• Perform stability studies on advanced intermediates, APIs and drug products
• Protocol in  accordance with ICH guidelines; long term, intermediate and accelerated conditions
• Store samples in qualified stability chambers under different conditions; 25OC/60% R.H.; 30OC/65% R.H.; 40OC/75% R.H.; refrigerator: 4OC, freezers: -20OC and -80OC
• Recommend storage/packaging conditions for re-test and expiry periods

Photostability Studies

• Perform photostability studies on APIs and drug products
• Conduct in adherence with ICH Q2B, option 2

Reference Standards Preparation and Qualification

• Prepare APIs, impurities and intermediates as reference standards
• Characterize and qualify as reference standards

Regulatory Support

• Provide support for IND, NDA and MAA submission
• Prepare DMF
• Prepare annual product reviews