Regulatory Guidance

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Regulatory Guidance
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As our services are customized to serve you, our sponsors' unique project needs, we will work collaboratively with you to provide the most appropriate and cost-effective solution to fit your unique technical requirements within your budget.
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Regulatory Guidance

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.

 

In short, you, the client, can rest assured that the regulatory strategy and study designs we propose comply with regulatory directives without adding additional cost in dollars and time.

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.

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