PROGRAM SPECIFIC METHOD DEVELOPMENT
Averica’s method development services help ensure that your team makes the best decisions and hits drug development milestones.
Analytical method development for all product development phases:
- Purity, potency (assay), and quantify specific impurities
- Stability indicating methods
- Chiral purity, chiral bioanalysis methods
- ICH Q11 support, e.g. for qualification of regulated starting materials (RSMs)
- Molecules with unique complexity or physical properties
- Modernization of legacy methods
- Development of product specification for commercial launch
Fit for purpose – for you and your molecule
As an independent analytical development and testing company, our focus is on methods that support your drug development program.
We recognize that our clients use many resources to bring a drug to market. Those resources: your internal team, CROs and CMOs need methods that produce consistent, reliable data for their work. We develop analytical methods that are robust, transferable, reproducible, and designed to generate quality results.
Our clients rely on our methods, and our business is to make sure that they can.
Averica evaluates and carefully considers each of the performance parameters and critical quality attributes (CQA) when developing a method.
- System Suitability
- Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ)
- Sample Stability
- Standard Stability
- Evaluation of Range
- Mass Balance
Averica’s scientists understand both the requirements of the method and the requirements of the compound. We define and evaluate key method parameters and identify critical quality attributes. Methods we develop are fit for purpose, ranged properly, and can be quickly validated.
The Averica Advantage
- Robust methods for fast method transfer.
- Emphasis on definition: making sure that a chromatographic method meets your needs and serves your development effort.
- Depth of experience with method development suited to challenging compounds and projects.
Custom assay design and physical properties testing.
Small scale assay development for when material is limited.
- SFC – Preparative & Analytical
- HPLC – Preparative & Analytical
- RP LC – Preparative & Analytical
Click for more information about how we use our technology systems.