karen and ed

Carmines Consulting LLC is a unique partnership between Ed and Karen Carmines. Karen's area of expertise is pharmaceutical clinical research and Ed's is pre-clinical (toxicology) evaluation of all types of consumer products including cigarettes, tobacco, food additives, and pharmaceuticals. Each has over 30 year's experience in their respective fields.

We are here to help!

We have broad experience in product development, testing, and evaluation. We can help you design safety and efficacy studies. We have experience with all types of consumer products and are well versed in FDA, EPA, and CPSC regulations. We can help you plan the studies, contract and monitor them and then write and/or review the reports. We can help you write product labels, investigator brochures, investigational new drug applications, new drug applications and material data safety sheets (MSDS). We have experience with many different therapeutic areas, biologics, and medical devices.

Some Of Our Services

Karen specializes in the monitoring of clinical trials. She is experienced in Phase I-IV clinical studies across multiple therapeutic areas.

Ed is a toxicologist with a broad background in consumer products. He specializes in safety evaluation of products. He has experience with FDA, EPA, and CPSC regulated products. He can help you design studies to meet regulatory requirements, contract the studies, and perform audits and review. He has experience with industry task forces/trade organizations and can represent you.