Bioteknica Inc is a well-established consulting firm based in Coral Gables, FL, specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the medical device, biological, and pharmaceutical industries. With over 25 years of experience, their proven methodologies and diverse technical skillsets fully prepare organizations for any regulatory challenge, aiming to enhance product quality, safety, and effectiveness in the healthcare industry.
As an ISO 9001:2015 certified company with global operations, Bioteknica Inc stands out among consulting firms, offering prompt response times and a comprehensive range of services, including training sessions, operational reviews, technical development, lean quality solutions, critical issue management, and more. Their professional approach, inclusiveness, and flexibility have earned them praise from clients, who appreciate their expertise in process validation and their ability to meet tight deadlines.
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