Analytical Method Development

Method Development / Validation

Zexa Labs has extensive experience in the development of analytical, bio-analytical, and microbiological methods.

Method Development

We have experience in developing analytical methods for the complete range of our analytical portfolio, and for the entire lifecycle of a drug. Typical applications are:

• Quality control of APIs, starting material, intermediates, finished products, impurities, and degradation products
• Stability testing
• Characterization of substances, identification of impurities and degradation products
• Forced degradation studies

Method Validation

At the method development stage, initial validation tests are performed to ensure that the method is reproducible and suitable for its intended use. When used in a GMP or GLP environment, methods are formally validated following the ICH Q2R1 guidelines, including preparation of validation protocols and reports. To provide cost-effective solutions, Zexa Labs offers validation programs adapted to the development stage of the drug, and in line with the customer’s internal quality requirements.

Testing Locations
Baddi, Himachal Pradesh

Contact Us
If you have additional questions about pharmaceutical testing or would like to consult with experts at Zexa Labs, just send us a request or call us at + 0179 545 6944.

Testing Options
Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, fill out the Sample Submission Form.