Facilities Start Up
Many clients come to Azzur concerned about the space, infrastructure, time, and financial investment necessary to start up a new facility. Often times these clients are a small startup biotech or pharmaceutical company, looking for a temporary space to enable early phase manufacturing (preclinical, development and Phase I/II clinical). To meet this need, Azzur has developed a GMP compliant space for startups to temporarily move in and get to work.
Azzur provides full-service project support for early phase pharmaceutical, biotechnology, medical device, diagnostics, biologics and clinical industry, as well as all HLS suppliers. Our capabilities include everything necessary for startups to succeed, from phase appropriate GMP program implementation, raw material receipt, testing, storage, calibration and qualification/validation services and cleanrooms for early phase GLP/GMP manufacturing.
Our space in Waltham, MA provides clients with:
Azzur can help establish phase-appropriate GMP programs for start-up clients including policies, procedures and related documents to ensure compliance with GMP regulations. Our quality professionals have a broad range of skill sets and experiences to implement risk-based programs fit for the specific phase of the product development and commercialization lifecycle.
Phase-appropriate implementation of GMP programs
Secure, qualified and monitored cleanroom space
Our cleanroom space is designed for early phase GLP/GMP manufacturing consisting of small batches, executed using disposable technologies. We have quality management systems compliance to GMP regulations, providing the necessary controls for such operations. This space is environmentally monitored to ISO 7/8 standards and has the capability to house ISO 5 environments (BioSafety Cabinets, Laminar Flow Hoods etc.)
Calibration and validation services
Azzur is capable of executing calibration and validation projects for companies of all sizes. We have our own NIST traceable standards and are able to execute calibration services at various clients sites or in-house in our Waltham, MA location. We have subject matter experts in all areas of qualification and validation, facilities, utilities, equipment, lab instruments and computerized systems.
Warehousing services and full-service lab testing
Our warehousing and laboratory services include short and long term storage of materials at various controlled temperatures, testing and release of raw materials intended for GMP use. Azzur Labs is capable of raw material, product, and facility/utilities (EM, gases, water etc.) testing that is compliant with various pharmacopeial and regulatory requirements.