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Safety Pharmacology - PharmaFacts
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Safety Pharmacology

Safety pharmacology is the required package of studies for investigational and new drug submissions that examines the functional effects of drug candidates on major organ systems. These studies may also provide mechanistic insights into potential issues of risk/benefit facilitating your drug obtaining approval for marketing by regulatory authorities.

PharmaFacts is the organization that can support your company in ensuring appropriate model selection and study design coupled with the choice of the best facility. This ensures the quality testing of your drug candidate. We then provide the critical report review and writing expertise. We work in partnership, offering solutions that will optimize both processes and procedures in your Safety Pharmacology (ICH S7A/B) and Preclinical Safety Assessment operations.

PharmaFacts brings together multidisciplinary teams of experts from the pharmaceutical industry, academia, and the corporate world. Our international experience in America and Europe and collaboration enable us to provide superior Preclinical Consulting Services:

  • Selection of Core and Investigative Preclinical Studies

  • Specialization in Cardiovascular and Renal Assessments

  • Placement and oversight at CROs and Academic Institutions

  • Statistics and Data Analysis

  • Worldwide Preclinical Safety Guidelines

  • Report Writing and Summaries for IND, IB, and NDA