Broughton Laboratories
Test Method Validation
We have extensive experience in validating analytical test methods for various applications and across a variety of product types in compliance with international regulations. We can assist throughout the entire method validation activity to meet your requirements. This includes project planning, protocol writing, execution, statistical evaluation and final validation report writing to satisfy your regulatory needs.
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Our analytical teams have particular expertise in method validation and developing analytical methods in the following key areas:
- Efficient and robust QC test methods
- Stability indicating test methods in compliance with ICH guidelines
- Methods for cleaning validation studies
- Dissolution and drug-profiling methods
- Compendial methods specific to your products
- Technology transfer validation projects