INDS Logo   Integrated Nonclinical Development Solutions, Inc.

Toxicology Services

Nonclinical safety program design and management, issue resolution, and regulatory submission preparation all require unique expertise to meet the high quality standards that your company and regulatory authorities expect. Due diligence inspections can be critical for your company’s success - whether you’re in- or out-licensing drug candidates.

Utilize the expertise of the INDS Team today.

Regulatory Submission Preparation

  • Pre-IND, IND, IMPD, NDA, MAA, IB
  • Representation at regulatory agencies

Expertise

  • General Toxicology
  • Safety Pharmacology
  • Genetic Toxicology
  • Clinical Pathology/Biomarkers
  • Carcinogenicity
  • Inhalation Toxicology
  • Impurities/Extractables/Leachables
  • Biologics/Biotherapeutics
  • Natural Products/Herbal Medicines
  • Hazard Notifications
  • Material Safety Data Sheets (MSDS)
  • Statistics/Data Evaluation
  • Process Improvement
  • Dispensary/Formulations
  • Vehicle Safety
  • Pediatric Drugs
  • Study Monitoring/GLP Regulations
  • Drug Device Combination Products
  • Medical Device Biocompatibility Testing
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Nonclinical Safety Program Design

  • Idea to registration
  • Traditional and innovative paradigms (including exploratory IND)
  • Mechanistic and investigative studies

Nonclinical Safety Program Management

  • Laboratory Qualification
  • Study placement and monitoring
  • Expert data and report review
  • Issue analysis and resolution
  • Risk Assessment
  • Pharmaceutical R&D

Due Diligence

  • Pharmacologic target evaluation
  • Conduct of and preparation for licensing and regulatory inspections
  • Merger/acqusition “clean team” review

Therapeutic Areas

  • Cardiovascular/Metabolic Diseases
  • CNS
  • Oncology
  • Inflammation
  • Dermatology
  • Infectious Disease
  • Women’s Health
  • Ophthalmology