Analytical methodology development
The team of A3Z advanced has an exhaustive know-how about developing and validating proprietary and non-proprietary analytical methods for:
- Excipients, APIs, intermediate products and finished products, according to the ICH Q2 and USP guidelines. Some available chemical tests are:
- General Identification Tests (HPLC)
- Assay (UV/Vis, HPLC by using multiple detectors, UPLC, LC-MS)
- Impurities identification (HPLC)
- Impurities determinations: degradation products, process and drug related impurities
- Small molecules (drugs, metabolites, amino acids, growth hormones) in biological samples from research and early development pharmacokinetic studies,
- Active ingredients from botanical sources.
Our know-how is currently applied in the analytical laboratories of pharmaceutical, nutraceutical, veterinary and cosmetic industries.
Simplicity and robustness are the two main properties of our analytical developments. An advanced procedure for method transfer to our sponsors is the third feature that defines our work. All of them are the apex of the triangle that supports the work of A3Z advanced.
Quality system evaluation (QSE)
For us, the regulatory compliance of our customers is a core question. Therefore the functionality of the quality system of our customers is evaluated continuously. A3Z advanced has developed a dynamic procedure to assess the quality system of our customers is fitted to its purpose and functional. Additionally, we check if it complies with the set criteria that includes:
- Evaluation of the effectiveness of the quality management system (FDA, EMA, ISO, ICH)
- Training and re-training of your laboratory staff
In addition to continuous evaluation, A3Z advanced can carry out an extensive internal evaluation of your quality management, operation and practices every year.
Our partnership philosophy includes a continuous support to the customer beyond the method transfer to the client’s laboratory. A3Z advanced offers a variety of support plans to fit your requirements in order to:
- Maximize your workflows and instrument productivity
- Ensure that your instrument is performing according to manufacture specifications
- Increase your laboratory efficiency by minimizing the number of failed analysis, unnecessary sample reanalysis and wasteful reagents consumption
What could be included?
- A3Z advanced® remote monitoring service
- Hardware and application telephone support
- Standard operating procedures available for the preventive/corrective maintenance your instrument application
- Enhanced on-site laboratory staff training/additional training of instrument operation and basic maintenance
- On-site application laboratory staff training and commissioning
- On-site visits to the client’s laboratory when required
The support plan is designed to help you to maximize application performance on a limited budget. If you want to make sure your systems are performing according to the defined specifications, our support plans are ideal.
For more information, send a email to email@example.com