We provide partial to total analytical development, method development and validation, method transfer, deformulation, counterfeit product identification, analytical laboratory services, consultative services, and HPLC/CE training with all work performed at your site. Method development experience includes 100s of classes of pharmaceutical, biotechnology, chemical, environmental, and nutraceutical molecules. We have extensive experience in GC and HPLC method development and many other areas, including GC, CE, LC/MS, GC/MS, UV/Vis, ICP, AA, GFAA, fluorescence, and other analytical techniques. We can help. FDA-Remediation/PAI Readiness/GAP Analysis Services
Method Development (MD)
Total or updating to conform with modern regulatory requirements, method parameter optimization, characterization and release/stability testing of APIs/raw materials/drug products/sample prep. Systematic optimization results in rapid, reproducible, robust, transferable, and, most importantly, approved methods.
Method Validation (MV)
Per FDA/ICH/EPA guidelines validation steps may include specificity, linearity, identity, assay, impurities, linearity, range, accuracy, precision, repeatability, intermediate precision, reproducibility, DL, QL, system suitability, ruggedness, and robustness. Full and partial validation depending on stage readiness.
Method Transfer (MT)
MT may involve comparative testing, complete/partial method validation or revalidation, covalidation between the two laboratories, or a transfer waiver. Starting with a protocol and ending with a transfer report, documentation is very important for the process and the results to satisfy regulatory compliance needs.
Cleaning Validation (CV)
Cleaning validation is the methodology used to assure that a cleaning process removes residues of the API ingredients of the product manufactured in a piece of equipment, the cleaning aids utilized in the cleaning process and the microbial attributes. WPBAD offers CV method development and validation services.
Deformulation and Counterfeit Product Identification
Whether it is identifying the ingredients in a competitor's product, % composition, batch-to-batch variations in raw materials, possible patent infringements, another company is spiking there product with your API, unbiased comparison of good vs. bad products -- let us answer these and other questions for you!
Consultative Services and HPLC/CE/Other Analytical Technique/Method Validation Training
WPBAD offers consulting and training in method development, method validation, method transfer, stress studies, laboratory instrument qualification (DQ, IQ, OQ, and PQ); introduction to HPLC, HPLC method development, GC, CE method development, UV/Vis spectroscopy, FTIR, TGA, DSC, ICP, AA/GFAA, dissolution, cleaning validation, pH meters, balances, and other courses.