BIOTEKNICA, INC.
CORAL GABLES, FLORIDA

BioTeknica specializes in regulatory compliance, FDA inspection readiness, quality engineering and validation projects. BioTeknica, Inc. BioTeknica is a consulting firm specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the Medical Device, Biologics, and Pharmaceutical industries. BioTeknica Mission Provide resolution to FDA compliance, regulatory and validation issues Bring proven industry experience and expertise – we are comprised of seasoned and highly skilled industry professionals who possess diverse skills and a full range of multi-disciplinary talents Provide hands-on, cost effective quality solutions and guidance through every stage of the manufacturing process Understand your business and adapt to your needs. We’re familiar with the industry’s production equipment, product development, processes, and quality systems which means minimal learning curve costs Partner with you and serve as extension of your team, supplementing your company’s resources to provide expertise in critical areas Since 1996, BioTeknica has helped clients solve significant business challenges. On the right are just a few of our success stories and case studies that demonstrate how we partner with our clients to help them reach successful resolutions to FDA compliance and validation issues. Careers with BioTeknica At BioTeknica we’re committed to creating an environment where our associates can achieve success while helping to keep products safe for patients worldwide. We are a motivated group of engineering and regulatory compliance consultants If you are a self-starter, enjoy rolling up your sleeves to get the job done, have industry experience, and are looking for a growth-oriented consulting firm to call home, then join our diverse team of professionals. At BioTeknica we’re committed to creating an environment where our associates can achieve success while helping to keep products safe for patients worldwide. We are a motivated group of engineering and regulatory compliance consultants who deliver solutions to our regulated life science clients, especially those in the medical device industry. If you are a self-starter, enjoy rolling up your sleeves to get the job done, have industry experience, and are looking for a growth-oriented consulting firm to call home, then join our diverse team of professionals. We look forward to hearing from you! Many of the world’s top life science companies turn to BioTeknica for regulatory compliance, FDA inspection readiness, quality engineering and validation services. BioTeknica Services SUCCESSFUL BUSINESS OUTCOMES…SUBSTANTIAL REGULATORY COMPLIANCE • Increasing productivity and profitability • Understanding how regulations apply to each specific product BioTeknica is ISO 9001:2015 Certified!