Blue Collar Scientific, LLC. Information

Blue Collar Scientific is focused on moving the business of drug discovery and development forward. Our expertise ranges from early stage lead seeking through IND filing. Our seasoned experts partner with thoroughly vetted contract research and manufacturing organizations to maximize efficiency with cost effective execution. BCS adapts to the needs of our clients regardless of the size of the project. With our extensive network of experienced Biotech and Pharmaceutical Development professionals, BCS can address a wide range of needs. AREAS OF EXPERTISE Drug Metabolism and Pharmacokinetics. Design of in vitro ADME and PK studies, interpretation of data and integration of learnings into the overall program. We work with CROs to generate key data to fill a documentation gap or solve specific problems. Bioanalytical Methods. Analytical methods are one of the most critical elements of any program; development, validation, and troubleshooting of rugged methods is a core strength. BCS is involved with a method from its genesis to support programs through Phase I. Analytical Development. BCS has extensive experience moving projects from discovery into the regulated world. Key functions include oversight of analytical methods development for API characterization, stability program design, and GMP manufacturing. Pharmacology & Toxicology. Development of preclinical pharmacology and toxicology strategy. Design, execution, interpretation and reporting of preclinical studies, clinical PK and biomarker data. Drug Formulations. Design and execute pre-formulation and formulation experiments to enable various forms of administration and delivery in support of preclinical and clinical drug development stages. Quality Assurance / Quality Control. Internal and external audits, implement quality management systems according to GMP or GLP guidelines, SOP development, compliance oversight and risk assessment.