Overview
Azzur of New England, located in Waltham, MA serves the biopharmaceutical and medical device industries with a variety of services including consulting, project management, calibration/maintenance, qualification/validation and regulatory compliance. In addition our Facility Startup Solutions offer secure, qualified and monitored cleanroom and warehouse space for product development and/or early phase GMP manufacturing and supply chain management. Our warehouse and raw material testing lab is designed for receipt, release and stoage (ambient and cold) of materials intended for GMP use. Our cleanroom space is designed for execution of small to medium scale early phase manufacturing batches in a classified ISO 7/8 enviroment, with aspetic operations performed under certified BSCs (ISO 5). Our niche is to enable biopharma/med device companies, to accelerate their product commercialization timlines, using phase appropriate, risk based approaches to establishment of GMP programs and providing cost-effective and compliant manufacturing and supply chain solutions.