Defining a successful (and appropriately scoped) preclinical strategy is an important component of the R&D pathway from Research to Development and to, ultimately, Commercialization. At Oculos, we take a hard look at our clients’ products, help establish a target product profile (TPP) and develop a preclinical strategy that will be acceptable to the global regulatory agencies. And, once the strategy is set and accepted (perhaps as part of a pre-IND meeting), Oculos will conduct the testing in our Rochester, NY facility. Our GMP, GLP and AAALAC-accredited testing facility can support your preclinical needs – pharma, device and diagnostic.
Examples of the services we provide in this space include:
- Preclinical development strategy
- Study design development
- Preparation of preclinical submission documents
- Manage IND/NDA/MAA preclinical programs
- In-vitro cytotoxicity testing
- In-vivo topical ocular studies (screening, acute ocular, dose range finding, repeat dose, ocular PK, etc.)
- Genetic toxicology
- Testing via intraocular (intravitreal / intracameral) and periocular (including subretinal injection) routes of administration
- Studies for contact lens and lens care products
- Full ISO 10993/biocompatibility services for ophthalmic devices
