Capabilities

GLP Toxicology

• Study design and study protocols
• Acute, repeated dose, carcinogenicity bioassays, reproductive toxicology programs
• Study monitoring including site visits
• SOP generation

Pharmacokinetics

• WinNonlin modeling (PharsightTM)
• Preclinical or Clinical

Pharmacology

• Vivarium set-up
• IACUC
• Design and monitoring of studies (Including study conduct in China)
• Murine xenograft models of cancer
• Primate proof-of-concept studies
• Numerous models including:
• Asthma
• Osteoporosis
• Multiple sclerosis
• Age-related macular degeneration

Regulatory

• From Research to Filing of Marketing Authorization
• Pre-IND meeting
• IND submissions
• Annual reports
• Investigator Brochure
• Clinical Pharmacology/Clinical protocols
• NDA/BLA submissions