We provide regulatory, quality, and clinical services to medical device and pharmaceutical companies at all stages of their development. View publications, co-authored by our founder, to learn more.
Principles For Medical Device Security
2016: AAMI TIR:57:2016 Principles For Medical Device Security - Risk Management
Quality Management System
2015: AAMI TIR48:2015 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Labs Prepare for Eventuality of FDA Oversight
2015: LDT Labs Prepare for Eventuality of FDA Oversight
Environmental monitoring for terminally sterilized healthcare products
2014: AAMI TIR52:2014 Environmental monitoring for terminally sterilized healthcare products
Inhaled Medicines: Past, Present, and Future
2022: Inhaled Medicines: Past, Present, and Future
Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter
2018: Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter
Pharmacokinetics of Paclitaxel Delivery for the Airway by a New Endobronchial Drug Delivery Catheter
2013: Pharmacokinetics of Paclitaxel Delivery for the Airway by a New Endobronchial Drug Delivery Catheter: Experimental Study
Macro and microscopic evaluation of paclitaxel delivery in the airway with a novel endobronchial injectable drug delivery catheter
2013: Macro and microscopic evaluation of paclitaxel delivery in the airway with a novel endobronchial injectable drug delivery catheter
Novel Toxicology Program
2020: Novel Toxicology Program to Support the Development of Inhaled VentaProst
Prediction of troponin elevation by means of intracoronary electrocardiogram during percutaneous coronary intervention of coronary bifurcation lesions (from Coronary Side Branch Residual Ischemia and Collateralization Assessment Study; COSIBRIA & Co Study
2016: Prediction of troponin elevation by means of intracoronary electrocardiogram during percutaneous coronary intervention of coronary bifurcation lesions (from Coronary Side Branch Residual Ischemia and Collateralization Assessment Study; COSIBRIA & Co Study
Dynamics and Control of Biofilms of the Oligotrophic Bacterium
2004: Dynamics and Control of Biofilms of the Oligotrophic Bacterium Caulobacter crescentus
Biotin in microbes
2003: Biotin in microbes, the genes involved in its biosynthesis, its biochemical role and perspectives for biotechnological production
Functional Analysis of Sinorhizobium meliloti Genes Involved in Biotin Synthesis and Transport
2002: Functional Analysis of Sinorhizobium meliloti Genes Involved in Biotin Synthesis and Transport
Direct Cloning from Enrichment Cultures
2001: Direct Cloning from Enrichment Cultures, a Reliable Strategy for Isolation of Complete Operons and Genes from Microbial Consortia