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Experience + Bio
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Call to anytime
+1 (970) 214-1588
Experience + Bio
Dr. Rajan Bawa
As the Chief Scientific & Institutional Officer of CARE Research, Dr. Bawa oversaw the technical and regulatory strategy for a wide host of preclinical drug and device developmental studies. These included both small and large animal studies and targeted diverse therapeutic areas, including pulmonary, ocular, cardiac, gastrointestinal, and nervous systems. Under his guidance, many preclinical projects were completed, with several undergoing clinical testing and some successfully marketed both domestically as well as internationally. This included testing in a large-animal model that facilitated accelerated FDA approval to enable clinical testing of a potential palliative/cure for patients infected with COVID-19.
Before his role at Care Research, as the President of Colorado Histo-Prep, Dr. Bawa oversaw histopathology and clinical chemistry functions. He also concurrently served as an Affiliate Professor of Biomedical Engineering at Colorado State University.
Before serving as president of Colorado Histo-Prep, he was Director of Research & Development at Atrix Laboratories (acquired by Tolmar in 2014), where he led the Drug Development group developing controlled release formulations and attendant processes, including oncology applications. These resulted in platform technologies for gelable drug delivery systems that underwent facilitated FDA approval. Before joining Atrix, Dr. Bawa served as Director of Drug Delivery at Alcon (1991) where he headed the development of unique ophthalmic formulations and designed processes and implemented strategies to obtain domestic and international regulatory approval, facilitating their successful commercialization.
Earlier in his academic career, Dr. Bawa conducted kinetic/microscopic investigations in polymeric controlled release, with Professor Robert Langer (M.I.T.), elucidating the hitherto unknown mechanism of channeled diffusion. Soon after his coursework at M.I.T., he joined Hoffmann-La Roche (1981), continuing his research in materials and processes for controlled release in pharmaceutical applications. He then joined Bausch & Lomb (1984) and worked on process and product applications for novel contact lenses as well as developing ophthalmic controlled release devices, the mechanisms of which were elaborated in his Ph.D. thesis.
He earned his doctorate in Chemical Engineering from the University of Rochester (1992) and two Master’ degrees, SM in Chemical Engineering & Nutritional Biochemistry/Metabolism from M.I.T. (1981).
Experience + Bio
Daniel Black
Mr. Black has over 40 years of experience in optimal and efficient study design, conduction, and writing reports with an established track record of successful FDA & EPA acceptance. These span a multitude of modalities, including DART (Developmental & Reproductive Toxicology). In fact, Dan authored the pertinent CFRs (Code of Federal Regulations) pertinent to teratology study design and conduct.
Additionally, Dan is a certified toxicologist and regulatory expert (QA professional).
Dan, too, was the past President of the Rocky Mountain Chapter of the International Society of Quality Assurance, prior to Dr. Bawa’s tenure.
We have over 150 years of collective experience in strategizing and executing, guiding the best regulatory strategy for your project to facilitate your timely approval by the FDA & EPA
As President of Colorado Histo-Prep and CEO/CSO of CARE Research, LLC and past President of the Rocky Mountain Chapter of the International Society of Quality Assurance, Dr. Bawa can help you to comply with FDA and USDA requirements and audits. Additionally, based on nearly four decades of successful product and process research experience Dr. Bawa can help you to identify optimal regulatory pathways at minimal expense.