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Professional Toxicology Services
"Grace’s experience allowed us to challenge and think through the best strategy to help address the known FDA’s concerns on our early product plan..."
ViroXis
Ian Clements, Co-founder, President & CEO
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Services

Professional Nonclinical Services
Discipline-specific expertise in key nonclinical areas is available to Paracelsus clients through highly knowledgeable and experienced professionals. Expertise is available in the following areas:

  • Pharmacology
  • Pharmacokinetics
  • Toxicology
  • Small molecule oncology [ICH S9] and non-oncology [ICH M3] development programs
  • 505(b)(1) and 505(b)(2) US registration strategies

Professional Veterinary Pathology Services
Veterinary pathology services are provided by an experienced, ACVP board-certified veterinary pathologist. Services offered include:

  • GLP-compliant processes, data and reporting systems
  • Rapid and flexible scheduling, fast turnaround times
  • Broad therapeutic expertise
  • Primary review, Peer Review or investigative pathology for all study types
  • Necropsy participation
  • Reporting

Regulatory/Submission-Level Document Preparation and Review
Paracelsus professionals deliver timely, high-quality nonclinical (toxicology, pharmacology and pharmacokinetics) contributions to global regulatory submissions including Pre-IND Information Packages, INDs/CTAs, Periodic Regulatory Reports (e.g., IND/NDA Annual Reports, PSURs), Investigator's Brochures and global product labeling documents.