Pine Lake Laboratories is a GLP and GMP compliant analytical and bioanalytical contract research organization located in Bristol, CT. We feature a state of the art laboratory with dedicated scientists that will deliver efficient and innovative solutions for even the most challenging projects. We have extensive experience in developing and validating methods for multiple applications, specialize in early development work and have a proven record of FDA compliance.
Our areas of expertise include:
• Extractable and leachables testing for pharmaceutical container closure systems and single-use bioprocessing equipment
• Analytical method development and validation to support combination product development
• Preclinical and clinical bioanalysis by LC-MS/MS
• Extraction studies on medical devices based upon ISO 10993-12
• CMC Analytical testing
• Short chain fatty acid analysis to support microbiome research