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
