Element’s robust analytical method development and validation services create efficiencies and ensure consistent results throughout the life cycle of your product.
Analytical method development and validation are crucial components of any pharmaceutical development program. 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.
As a fully Good Manufacturing Practice (cGMP) compliant laboratory, Element offers innovative analytical method development and validation solutions that make sure the procedure is best suited for the intended use at the various stages on the way to market.
Analytical method development and validation services
- Development of entirely new analytical methods to optimization or improvement of outdated procedures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 leachables studies
- Physical characterization for analytical method development and validation
- Development and validation reports along with method transfer services
Analytical method development and validation instrumentation
Our laboratories are equipped with state-of-the-art spectroscopy instrumentation to support our method development activities and achieve high quality and reliable analytical data, including time of flight mass spectroscopy and cGMP 500 MHz Nuclear Magnetic Resonance (NMR).
Analytical method development and validation capabilities
Our highly skilled Engaged Experts prepare and execute validation protocols based on a workable method in compliance with regulatory guidelines, such as the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH). Using their experience and expertise, our lead scientists will work with you to understand your specific project needs and develop a customized plan for your product’s analytical development.
Standardized and efficient analytical method validation
We develop standard operating procedures and analytical method validation transfer protocols for the transfer of the validated method to our clients’ laboratory. Element’s analytical method validation packages have been included in many regulatory applications.
The Element advantage
Element'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, minimize duplication of effort and offer accurate, reliable and consistent data.
For more information about our analytical method development and validation services or to request a quote, contact us today.
Forced Degradation Studies
Element’s forced degradation, stress testing services per ICH Q1A guidelines assess the stability of drug substances or drug products with effects on purity, potency, and patient safety.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.
Discover blog posts, articles, white papers, webinars, and advice from our world-leading testing, inspection, and certification experts.
Learn more about our laboratories - where they are located; the unique capabilities they have and how they can help you solve your technical and commercial challenges.