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Pharmaceuticals


We have conducted, perhaps, more chemical risk assessments than any other consulting firm in America and thus, we are uniquely positioned to offer strategic and scientific experience to pharmaceutical manufacturers dealing with questions concerning labeling and risk assessment aspects of product safety.

We have the capability to provide support for our clients at critical points in the drug discovery process. At any point along the continuum--from preclinical research to new drug application review and post-marketing studies--our team can help ensure that a drug will pose no extraordinary risk to consumers. (We are well qualified to assist clients in developing properly focused worldwide regulatory applications that result in rapid product approvals). We can also provide product-specific assistance for any type of drug at critical points during the discovery, safety assessment, manufacturing and control study, efficacy assessment, and environmental assessment phases of bringing a drug to market.

We have extensive experience on conducting risk/benefit analysis and profiles, and with the current regulatory emphasis on new products, we are well qualified to assist clients in developing properly focused worldwide regulatory applications.



  • Galbraith,D.A. 2005. Judgement Day for Cox-2 Inhibitors, or Just Another Day? Pharmaceutical Law & Industry Report, 2005;3:233-5.




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