Paracelsus
Paracelsus, Inc. specializes in professional nonclinical safety testing and toxicology services for the pharmaceutical industry. Led by CEO/President Grace M. Furman, PhD, the company offers expertise in nonclinical safety programs, regulatory document preparation, and due diligence projects to support drug development and registration. The company aims to help organizations meet the challenges of pharmaceutical R&D with customized strategies and high-quality services.
Industries
Nr. of Employees
small (1-50)
Paracelsus
Encinitas, California, United States, North America
Services
Consulting to design integrated nonclinical safety programs tailored to intended clinical indications and acceptable to global regulatory authorities.
Preparation and critical review of nonclinical safety sections for regulatory submissions including pre‑IND information packages, IND/CTA submissions, periodic safety reports, and investigator brochures.
Independent critical review of nonclinical safety data to support partnering, licensing, or investment decisions from a developer or potential partner perspective.
Subject-matter expert consulting in general toxicology, genetic toxicology, developmental and reproductive toxicology, and safety pharmacology to inform study design and data interpretation.
Consulting to design integrated nonclinical safety programs tailored to intended clinical indications and acceptable to global regulatory authorities.
Preparation and critical review of nonclinical safety sections for regulatory submissions including pre‑IND information packages, IND/CTA submissions, periodic safety reports, and investigator brochures.
Independent critical review of nonclinical safety data to support partnering, licensing, or investment decisions from a developer or potential partner perspective.
Subject-matter expert consulting in general toxicology, genetic toxicology, developmental and reproductive toxicology, and safety pharmacology to inform study design and data interpretation.
Expertise Areas
- Nonclinical safety assessment
- Toxicology consulting
- Developmental and reproductive toxicology (DART)
- Safety pharmacology
Key Technologies
- Genetic toxicology assays
- Developmental and reproductive toxicity testing
- Safety pharmacology testing
- Nonclinical study design