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

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