A robust analytical method creates efficiencies and ensures consistent results throughout the lifecycle of your product.
Analytical method development and validation are crucial components of any pharmaceutical development program. Methods validated to regulatory guidelines ensure that the procedure is best suited for the intended use at the various stages on the way to market.
Approved methods establish clear limitations of application and verify that the process is resilient enough so that slight variations between operators or between laboratories do not have a material impact on results.
Exova offers innovative analytical method development and validation solutions including:
- Development of entirely new analytical methods to optimization or improvement of outdated procedures
- Testing methodologies for identification, limit and quantitative impurity determinations
- Development and validation of stability-indicating assays, including forced degradation studies
- Design of limit tests (e.g. surfactants) to support clearance and cleaning validation studies
- Extractables and leachable studies
- Physical Characterisation for analytical method development and validation
State-of-the-art spectroscopy instrumentation, including time of flight mass spectroscopy and cGMP 500 MHz Nuclear Magnetic Resonance (NMR), supports our method development activities. We prepare and execute validation protocols based on a workable method in compliance with the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH) guidelines. We also provide comprehensive development and validation reports along with method transfer services.
Standardized and Efficient Analytical Method Validation / Analytical Method Development and Validation
Exova’s extensive scope of analytical method validation experience allows us to quickly generate validation protocols that meet analytical method validation and regulatory demands. Corresponding analytical method development and validation programs are efficient and minimize duplication of effort.
Standard operating procedures and analytical method validation transfer protocols are developed for transfer of the validated method to our clients’ laboratory. Exova’s analytical method validation packages have been included in many regulatory applications.
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1300 First State Blvd, Suite C,
Wilmington, DE 19804
Contact: Waheed Sheikh - President
Tel: +1 302-636-0202
Fax: +1 302-636-0204