• World wide regulatory affairs
  • Development strategy and candidate selection
  • Selection and supervision of CROs
  • Quality assurance - GLP, GCP, GMP, ISO
  • Nonclinical and clinical project management
  • Toxicology: General; Genetic & In Vitro; Reproductive & Developmental; Inhalation
  • Pharmacokinetics, ADME
  • Dermatology and wound healing
  • Histopathological and fetal evaluation
  • In vivo compatibility and degradation
  • Medical/technical writing, literature searches, data mining and reviews
  • Regulatory documentation: expert reports and overviews, CTDs, investigator brochures, clinical trial applications etc
  • Product registration