18 Since its foundation in 2010, Azzur Group has strived to lead the healthcare and life science industries with its phase-appropriate quality and compliance services. As early-stage manufacturers embark on their journey of researching, developing, and piloting their products, a lack of manufacturing infrastructure and compliance expertise can be a major obstacle. Furthermore, when start-ups make the transition from early-phase manufacturing to full-scale operations the decisions they make are critical. Azzur guides manufacturers through the whole process, allowing them to execute risk-averse strategies to accelerate product development. Beyond this, Azzur’s solutions can help them maintain these strategies and continue to comply with necessary regulations. In the production of products like medical equipment and pharmaceuticals, a cleanroom is essential to ensure the quality of the product. Cleanrooms are controlled environments that filter pollutants like dust, airborne microbes, and aerosol particles to provide the cleanest area possible. Traditionally, as life science innovators begin their journey, they have two choices when it comes to early clinical trial manufacturing: build or broker. Azzur’s Cleanrooms on Demand™ facilities offer current Good Manufacturing Practices (cGMP) compliant cleanroom spaces, warehousing, and material management, allowing manufacturers to carry out their daily activities without the need to build their own facility or rely on Contract Manufacturing Organizations (CMOs). When companies obtain a license for an Azzur Cleanroom, they receive all the added benefits of building their own facility without the timeline setbacks or cGMP compliance technicalities. Unlike with CMOs, Azzur’s hybrid model allows them to maintain full control over their space and all intellectual property developed in the facility. The cleanrooms also come fully equipped and customizable to meet the needs of very specific industries. They require no maintenance, are fully secure, and can be used freely without schedule restrictions. 2022’s Most Innovative Medical Aesthetic & Plastic Surgery Clinic - London Breaking Down the Barrier Between Eastern and Western Aesthetic Treatments Feb23518 When scaling up from research and development to a manufacturing process, life science companies must invest in building a foundation for Good Manufacturing Practices (GMP). For this, training all personnel is essential. However, shutting down a facility to provide training reduces productivity and therefore turnover, meaning it can be costly for a business. Azzur’s Training Center (ATC) covers a range of Good Practice (GxP) concepts, specializing in aseptic manufacturing, a method of manufacturing that allows production in the absence of bacteria without terminal sterilization processes. ATC works with top pharmaceutical, biotechnology, and medical device manufacturers to deliver hands-on learning based on the client’s specific company procedures. Azzur’s trainers become certified on these protocols and techniques, which employees are then trained on at ATC. This means that the client does not need to sacrifice manufacturing space to provide training, allowing productivity to be maintained by eliminating the need for facility shutdown. Throughout the whole product development life cycle, from research and pre-clinical processes to commercial launch, manufacturers consistently face obstacles in achieving, maturing, and maintaining GxP compliance. After devoting decades to research and development, it is no surprise that manufacturers are often eager to deliver their products to patients safely and quickly. However, even the most experienced manufacturers are affected by GxP compliance issues, which can impact production capacity, generate costly downtimes, and even impact their ability to supply products to patients. With an extensive network of engineers and consultants across the nation, Azzur Group offers GxP advisory and consulting solutions, including comprehensive quality assurance and regulatory compliance services, to manufacturers in every phase of the product life cycle. When it comes to compliance, quality, and safety, it is important for any GxP organization to maintain a validated state. Azzur Group specializes in commissioning and qualification, process validation, and cleaning validation, ensuring these organizations have the people, processes, and procedures necessary to meet the standards of leading regulatory bodies. Azzur’s qualified cGMP consultants are highly familiar with these standards, including the guidance provided by the FDA, EMA, and other bodies. No matter where clients are in the product life cycle, Azzur is sure to set them up with success, enabling them to sustain effectiveness, efficiency, and high quality. The process of moving from drug discovery to delivery is complex and requires extensive laboratory testing. Founded in 2012, Azzur Labs is a contract laboratory serving the pharmaceutical, medical device, and biotechnology industries. Azzur believes companies within these industries all have the potential to make ground-breaking discoveries, so it strives to aid them in their pursuit to achieve their goals. To do this, the laboratory assists with its analytical testing and ensures regulatory compliance. Azzur Labs offers a range of services, including environmental monitoring, textile testing, and microbiology and chemistry testing, consistently providing valid and accurate results. Clients who choose to outsource their calibration services with Azzur can trust that it will always exceed expectations, working hard to meet its client’s needs. From Discovery to Delivery™, Azzur Group, LLC provides the life science community with innovative quality and compliance solutions. With laboratories, training centers, cleanroom facilities, and consulting and advisory offices across the nation, Azzur is dedicated to helping organizations start, scale, and sustain their enterprises. Over the years, the company has become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chains. Leading Innovators in Early-Phase Biotech Manufacturing 2023
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