Nonclinical Pharmacology/Toxicology

Evaluating the Nonclinical Safety of Drug Products

Our nonclinical development team is made up of industry experts with decades of combined scientific, technical, regulatory and test lab experience, and offers full service nonclinical pharmacology and toxicology support across drugs, biologics, cell and gene therapies, and combination products.  Our services include nonclinical regulatory strategy, study oversight and safety assessments.  We support our clients throughout the FDA submission process from Pre-IND through market authorization. Our team helps to streamline the nonclinical development process and optimizes chances for regulatory success.

• Early-stage nonclinical program development, including regulatory gap analysis, due diligence, and strategic product “roadmap” development plan
• GLP safety testing support, including test lab selection, study design and protocol review, study monitoring and oversight, and review of study reports for compliance
• Assistance with study report authoring, including pharmacology and non-GLP reports
• Regulatory submission support, including scientific writing, reviewing, and providing strategic input on FDA INTERACT and Pre-IND meeting packages and IND and BLA or NDA marketing applications
• Participation in FDA meetings and Agency feedback interpretation 
• Safety assessments for all types of drug products and disease indications
• SEND Explorer analysis and interrogation of nonclinical data in the same manner as FDA reviewers
• Excipient, impurity, and extractables and leachables safety assessments for drug products, container closure systems, and drug delivery devices
• Pharmacokinetic and pharmacodynamic (PK/PD) support
• Pharmacovigilance (PV) and risk management plan development
  
  

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