Small Molecule GLP and Non-GLP Bioanalytical Services supporting all phases of drug development via state-of-the-art facilities.
Impact Analytical Staff have over 30 years’ experience in conducting regulated bioanalytical studies supporting the development of small molecule pharmaceuticals and biomarkers from our facility in Midland, MI.
Our laboratory uses a wide range of techniques and technology platforms to meet the needs of our customers and more, in support of PK/TK, pharmacology, bioequivalence and bioavailability studies, and biomarker assays from early discovery to post marketing. Bioanalysis is somewhat unique in that it is required for the evaluation of a therapeutic throughout the entire drug development cycle.
Available Bioanalytical Services for Preclinical and Clinical Studies
- Method Development/Transfer
- Method Validation
- High Throughput sample analysis
- Bioanalytical support of Lead Optimization Studies
- Pharmacokinetic (PK) and Toxicokinetic bioanalytical support
- Biomarkers Assays via LC-MS/MS
- Stabilization of labile compounds and sample analysis
- Tissue sample analysis
- Bioanalytical support of Drug-drug interaction studies
- Dose Formulation Analysis
- Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
- Metals and Elemental Bioanalysis by ICP-MS
- Rapid Discovery Phase Bioanalysis
- Bioanalytical Technologies including Liquid Chromatography - Mass Spectrometry (or with High Resolution Mass spectrometry), Gas Chromatography/FID/ECD, Gas Chromatography-Mass spectrometry, and Inductively Coupled Plasma-Mass Spectrometry.
Our laboratory focuses on science, compliance, customer service, and efficient delivery of data. All of our team works hard to deliver exceptional services, delivering data that meets your timeline. Personalized service and one on one communications with the analytical team ensure the seamless transfer of data. Our 30+ scientists, equipped with the latest technologies, are committed to solving your challenges with scientific excellence.
From method development or transfer and validation, to sample analysis and reporting, Impact’s analytical team has earned a reputation for consistent and high-quality delivery, project after project.
Our people are at the heart of our business. Our scientists have extensive experience in analytical testing in labs dedicated to drug development. Our lab management team members have at least 25 years of experience in contract laboratory environments. Additionally, our executive management team brings expertise and longevity, with each having more than 30 years of industry experience.
We leverage the experience of our leaders, managers, and scientists to effectively meet clients’ requirements of accurate, timely, high-quality results with:
Efficient, timely support of complex analytical challenges
Advice on procedures/methods to obtain the needed data
Refined analytical standard operating procedures (SOPs) and lab procedures
Our comprehensive analytical SOPs ensure compliance with good laboratory practice (GLP) and good clinical laboratory practice (GCLP) standards as well as current regulatory guidance documents.
Unsurpassed Regulatory History
Given the sophistication of today’s pharmaceuticals and the complexity of the development process, an analytical lab partner with broad technical expertise and a strong regulatory history/performance is more important than ever. In a recent Industry Standard Research (ISR) survey, respondents noted technical expertise and regulatory history/performance as the most important criteria for selecting an analytical lab.