PLS Analytical
PLS Analytical, established in 2016, is a leading pharmaceutical and microbiological testing laboratory based in East Brunswick, New Jersey. The company is committed to providing high-quality, customer-focused analytical testing services for pharmaceutical, dietary supplements, and packaging industries. It operates a cGMP facility, follows FDA and USP guidelines, and offers a wide range of testing services including chemical, microbiological, endotoxin, elemental impurities, and environmental monitoring. PLS Analytical aims to ensure the safety, efficacy, and regulatory compliance of pharmaceutical products through innovative and reliable testing solutions.
Industries
Nr. of Employees
small (1-50)
PLS Analytical
40E Cotters Lane, Suite A, East Brunswick, NJ-08816
Services
Laboratory testing for APIs, excipients, contaminants and finished products including chromatographic and spectroscopic analyses.
Endotoxin testing, sterility testing, microbial identification using molecular and proteomic methods, and environmental monitoring.
Development of analytical methods to quantify APIs and characterize formulations for downstream R&D and manufacturing.
Validation and suitability testing of analytical and microbiological methods per USP/ICH/FDA requirements.
Transfer and documentation of analytical methods between laboratories or to manufacturing sites, including acceptance testing and deviation records.
Design and execution of cleaning verification protocols including TOC-based method development and verification.
Laboratory testing for APIs, excipients, contaminants and finished products including chromatographic and spectroscopic analyses.
Endotoxin testing, sterility testing, microbial identification using molecular and proteomic methods, and environmental monitoring.
Development of analytical methods to quantify APIs and characterize formulations for downstream R&D and manufacturing.
Validation and suitability testing of analytical and microbiological methods per USP/ICH/FDA requirements.
Transfer and documentation of analytical methods between laboratories or to manufacturing sites, including acceptance testing and deviation records.
Design and execution of cleaning verification protocols including TOC-based method development and verification.
Expertise Areas
- Analytical method development
- Method validation and verification
- Microbiology testing and microbial identification
- Environmental microbiological monitoring
Key Technologies
- Total Organic Carbon (TOC) analysis
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Atomic Absorption Spectroscopy (AAS)
- Limulus Amebocyte Lysate (LAL) endotoxin assays