Oasis Test House offer service "Method Development and Validation services"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
Method Development and Validation services
Service Provider(s)
Specifications
- Service Category: Analytical method development and validation services, including process-validation, cleaning-validation, and water-validation sample support, carried out per ICH guidelines.
- Regulatory Certification: Methods are developed and validated under a documented protocol-approval-report workflow aligned with ICH guidelines; beyond this, specific certifying bodies are not detailed in the listing.
- Capacity Scale: Batch/capacity scale is not disclosed in the listing; production is positioned for commercial contract-service volumes.
- Geographic Coverage: Geographic coverage is not detailed in the listing; the supplier serves regional and international pharmaceutical customers.
- Lead Time: Lead time is not specified in the listing; it is confirmed directly with the supplier at the time of order.
Other Information
Additional Description:
Oasis Test House follows systematic procedures to guide customers through method development and validation, with a qualified team competent in developing and validating methods per ICH guidelines. A validation protocol is drafted and shared with the customer for approval before the study begins, with parameters tested regularly throughout; a validation report is issued once the process is complete. Areas of work include analytical support for process validation, cleaning validation, and water validation studies.
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