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.