Our team of experts is having the rich experience in developing, optimizing and validation the methods as per international guide lines such as:
- ICH CGP & GLP
- US FDA
- EuraChem
- European
- AOAC
- Customer provided
Our expertise in Method Development and Validation ranges in
- Assay/Potency, Purity/Impurity, Dissolution
- Cleaning Validation Analysis (Specific and Nonspecific analyses)
- Assay, Impurity and Dissolution methods for Comparator products
- Residual/Impurities Testing
- Leachables and Extractables
- Excipients
- Antimicrobial Efficacy Test
- Microbial Limit Test
- Bacteriostatis/Fungistatis for Sterility
- Inhibition/Enhancement Screening for Endotoxin
- ELISA
- Thermal Cycler and qPCR
Protocol Writing for
- Method Validation / Qualification / Verification
- Method Transfer
- Stability Studies