Analytical and Regulatory Support

AGIL’s regulatory and quality support teams support partners in developing validation master plans, batch records, investigation reports, validation summaries, annual products review and Drug Master Files.

Key areas of focus includes:

• Analytical method development
• Degradation / Stability studies
• Analytical method validation
• In-process/ intermediate/final product analysis
• Method transfer to multi-side

Impurity profiling

• Team of experienced organic chemists to synthesize milligram to multi-gram scale of compounds
• Experienced scientists for identification and characterization of novel chemical entities using modern methods of analysis
• Identification, structure elucidation and characterization of impurities
• Degradation study to prove the method developed is stability indicating
• Photo stability studies as per ICH guidelines
• Real time and Accelerated stability studies as per ICH guidelines