Bioteknica is a renowned 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 fully prepare organizations for any regulatory challenge, offering prompt response times and a diverse range of technical skillsets.
Their vision is to enhance healthcare by partnering with manufacturers to improve product quality, safety, and effectiveness. As an ISO 9001:2015 certified company with global operations, Bioteknica is known for their professionalism, inclusiveness, and expertise in areas such as process validation, critical issue management, and FDA inspection readiness.
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