Working Practice, Method Development & Validation

Bio analysis for Clinical Trial Samples, tested to high standards tailored to your specific Biopharmaceutical needs.

Resources

• Sample collection, handling and storage
• LC-MS-MS, GC-MS, HPLC
• Radioisotope counters
• Electronic sample tracking

Preparation

• Meetings with Sponsor
• Confidentiality Agreement
• Review Study Protocol
• Work Agreement & Schedules
• Project Management requirements

Development

• Specialists in analysing unusual body fluids (eg. Biopsy tissues, Fecal, Gastro duodenal, Saliva, Sweat, Synovial)
• Specialists in validating assays for novel drug delivery applications (eg. Transdermal, Transpulmonary)

Validation

• Appointment of Study Director
• Bioanalytical Protocol approved by Sponsor
• Validation Study Plan
• Validation to standard accepted for regulatory approval

Please contact us for details of analytical methods.

Click here for a list of publications