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Professional Toxicology Services
"We have had the great pleasure to work with Grace at Paracelsus on ENDECE’s lead oncolytic candidate, NDC-1308, and now consider her to be our “go to” person for toxicology...."
Endece
Dr. James Yarger, 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.