PPL, Inc. offers world class expert service on the most challenging projects in chemical, manufacturing and control (CMC) technical area. For regulatory compliance, various stage projects are conducted under phase-appropriate cGMP guidelines. The wide range of services areas include, but is not limited to the following areas:

     • Analytical Method Development
     • Stability-Indicating Methods
     • Excipient Compatibility Studies
     • Degradation Product Identification
     • Method Validation and Transfer
     • Chiral Separation
     • Release and Stability Testing

PPL, Inc. is also proud to offer same day rush services for in-process testing and releases for bay area biotech companies. The fast turnaround time allows our client to make real time data-based decisions.

PPL, Inc. offers a wide range of laboratory and consulting services in the PPDM area. PPDM is an important area during new drug development, including small molecules and protein pharmaceuticals. PPL has accumulated significant expertise in this area, and is proud to share its expertise and knowledge with its clients. PPL also offers cGLP bioanalytical testing services based mainly on HPLC/MS/MS technology.

PPL's PPDM services include, but is not limited to the following areas:      • Study Design and Consultation Services      • Confidential consultation services      • PK sample analysis      • Method development/validation      • cGLP sample analysis      • Data management and analysis      • Pharmacokinetics/pharmacodynamics Modeling and simulation .      • Reports for submission      • Regulatory submission document preparation      • Drug Metabolism Studies      • Metabolic profiling      • Enzyme inhibition/induction      • In vitro permeation studies (CACO-2, etc.)      • Metabolite identification      • Metabolite synthesis (e.g. glucuronides: mg to 100 mg range)