Capabilities

Specialized Areas of Expertise and Experience
  • Primary Expertise: Inhalation toxicology and respiratory pharmacology
  • Other Indications: Inflammatory, Cardiovascular, Gastrointestinal, Ophthalmology and Arthropathies 
  • Routes of Administration: Inhalation, intranasal, intra-articular and intravitreal administration
  • Modalities: Recombinant and engineered proteins, oligonucleotides, antibodies, peptides, small molecules, PEGylated molecules and drug-device combinations
Pharmacology and Toxicology Strategy and Development
  • Develop toxicology strategies from IND to registration
  • Design, implement, monitor and interpret nonclinical studies
  • Identify, select, initiate and oversee CRO studies
  • Define and manage animal model & safety pharmacology programs
  • Perform nonclinical due diligence for acquisitions
Document Preparation and Review
  • Regulatory quality (GLP) reports
  • Regulatory submission preparation
  • Investigational brochures
  • Board or partnering presentations
  • Manuscripts and white papers