Pre-Clinical Studies

  • in vitro cytotoxicity tests
  • in vivo topical ocular studies
  • testing by intraocular (intravitreal and intracameral) and periocular routes of administration
  • studies for contact lenses and lens care products
  • ocular pharmacokinetics
  • Full ISO 10993 / biocompatibility services for ophthalmic devices
  • AAALAC-accredited small animal vivarium

Chemistry Manufacturing Controls (CMC)

  • Formulation development (solution, suspension, emulsion, ointment, solid-dose)
  • Manufacturing of materials for clinical trials
  • Selection of contract manufacturer
  • Manufacturing process transfer
  • Set-up of Quality Assurance systems and procedures
  • Preparation for FDA inspections

Clinical Trials Design and Execution

  • Trial design
  • Protocol writing
  • Site selections
  • Investigator meetings
  • CTM labeling/distribution/logistics
  • Electronic data management
  • Site monitoring
  • Biostatistics
  • Study reporting

Regulatory Strategies and Submissions

  • Write protocols
  • Write and file IND
  • Write and file orphan product designation
  • Write study reports
  • Write and file NDA (eCTD)
  • Document review and collection
  • Preparation of FDA briefing packages
  • FDA meeting representation