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ANDA/505 B 2 submissions

SRC is focused on PK end-point (ophthalmology, oncology) & clinical end-point study management for ANDA/505 B 2 submissions. We have pre-selected a number of sites with the inclination and resources to conduct these studies and monitors adept at identifying and resolving issues specific to the implementation of these protocols. The team is well integrated with SRC’s bio-analytical department for seamless and cost effective PK solutions. Every aspect of our generic management capability is built to ensure your product’s time-to-market is quick and cost effective.

Project Phase Number of patients Sponsor
Ophthalmic suspension (PK in aqueous humor) Pilot 24 US Pharma
Ophthalmic suspension (PK in aqueous humor) Pivotal 552 US Pharma
Ophthalmic ointment (PK in aqueous humor) Pilot 54 US Pharma
Ophthalmic solution (Therapeutic equivalence) Phase III 286 US Pharma

About This Service

SRC offers comprehensive Phase I-IV services for drugs, devices & diagnostics.  The team is well-entrenched in regulated market requirements & GCP. Our collective goal is to shrink your time-to-market through superior scientific expertise and trial management innovation.