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Analytical method development, validation, and transfer are key elements of any pharmaceutical development program and are important first step to determine that analytes of interest can be reliably detected and quantified for routine sample analysis. Often considered routine, the benefit that well-developed analytical methods can contribute to the overall developmental time and cost efficiency of a program is undervalued. We specialize in developing the right method that can be reproducibly estimate the analyte of the interest.
Invitron has vast experience in analytical method development and validation for a widest variety of platforms including HPLC, LC/MS/MS, GC/MS/MS, GC/FID, ICP/MS . Our team includes lead scientists who have over 20 years experience in method development and validation. Based on our extensive experience with complex products spanning across widest dosage formats possible, Invitron can swiftly develop the most appropriate method for your product in-line exceeding the expectations of regulatory agency.
Invitron offers cost-effective strategic approach to analytical method lifecycle management, which combines method development, refinement, qualification, validation, transfer, and maintenance related to GMP production. Our holistic package approach to analytical method lifecycle has been deployed in various of projects and are best suited for the intended use at the various stages on the way to product commercialization.
1. Analytical Method Development
2. Analytical Method Optimization
3. Analytical Method Validation
4. Analytical Method transfer