Pharmaceutical Analysis Contract Services

BASi scientists can provide support for all phases of your drug development, from early stage API method development to post-commercialization product testing. Our testing is completed in compliance with all appropriate regulations (cGMP, GLP), and we welcome projects which are analytically challenging. We believe strong lines of communication between our business and yours are essential to the successful completion of projects, and we will customize our approach to meet your unique demands. From your initial inquiry to the final report, BASi will be with you each step of the way.

Pharmaceutical Analysis Services include:

Drug Development Services

• NDA, IND and QC stability program support
• Method development and validation
• Forced degradation studies
• Final product release testing
• Comparator testing
• Dosing solution analysis
• Compendial testing
• Formulation development support
• Stability storage on site
• In Vitro bioequivalence

Dosage Forms Analyzed

• Solids, API, capsules, tablets
• Liquids
• Semi-solids, suspensions
• Drug-coated medical devices
• Transdermal patches
• Cytotoxic and potent materials
• Controlled substances (Schedule 1 - 5)

Testing Capabilities

• High Performance Liquid Chromatography
  • UV/Vis
    
• Tandem mass spectrometry (LC-MS/MS)
• Electrochemical
• RI detection
• Ion chromatography
• GC with headspace capability
• Dissolution testing
• Particulate matter analysis
• Polarographic analysis
• Most standard analytical tests

Benefits

• Strong technical staff
• Scientist-to-scientist communication promotes partnering
• Quality data delivered to meet timelines
• Project flexibility
• Program size: Single sample analysis to multi-faceted stability program
• Final report format: C of A, stability table or client defined, all with option of electronic format with electronic signatures
• Methods used: Compendial, BASi-developed or client-supplied

Quality

• Robust QC/QA data review
• Client on-site audits always encouraged
• GMP FDA inspection — 2011, 2006, 2003, with no 483s
• GLP- and cGMP-compliant
• GMP Audit Certificate, Forum auditorias (ref #232)

Submitting Pharmaceutical Samples to BASi

• Pharmaceutical Sample Submission Form
  Use this form to inform BASi of samples that will be shipped. Please print a copy of the completed form to include with the shipment before clicking on the Submit to BASi button.