Regulatory Submissions

Pre-Clinical Services

Ø  GLP Study Management

    o    Safety pharmacology

    o    Toxicology:

                       ·   Acute, subchronic

                       ·   Genotoxicity

                       ·   Carcinogenicity

                       ·   Reproductive

                       ·   Immunotoxicity

     o    ADME

Ø  GLP compliance

Ø  Clinical bioanalysis

Ø  Pharmacokinetic assessment

Ø  Analytical assay:  development and validation

Clinical and Commercial Supply
Clinical Development
Product Development
Validation Services
cGMP and GCP Audits
Quality Systems