SPECIALTY SECTORS
Biologic License Applications for human tissue products
BLA experience includes design and implementation of identity and potency assays and execution of safety and efficacy preclinical studies for amnion derived products. Services include but not limited to:
-
Design and execution of potency and identity assays consulting and management
-
Protocol development and review
-
Preclinical development and execution of studies
Cardiovascular Devices
Experience includes project management of product development projects and execution of safety and efficacy preclinical studies for carotid patches, cardiovascular repair patches and heart valves derived from porcine SIS. Expert in executing design control projects in accordance with FDA heart valve guidance. Services include but not limited to:
-
Design and execution of preclinical studies to show safety and efficacy
-
Protocol development and review
-
Design control documentation for development
-
Development of extracellular matrix repair patches, stents, and heart valves (heart valve expert in mechanical and biologically derived valves)
Wound Care Device and Biologics
Experience includes project management of product development projects and execution of safety and efficacy preclinical studies for porcine SIS and amnion derived products. Services include but not limited to:
-
Design and execution of preclinical studies to show safety and efficacy
-
Protocol development and review
-
Design control documentation for development
Women’s Health Device and Biologics
Experience includes project management of product development projects and execution of safety and efficacy preclinical studies for polyproplylene mesh, porcine dermis and amnion derived products. Services include but not limited to:
-
Design and execution of preclinical studies to show safety and efficacy
-
Protocol development and review
-
Design control documentation for development