| |
|
| | Our Offerings |
| |
|
|
| |
Analytical and regulatory support |
| |
Shasun’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
|
 |
|
| |
|
|
