BioTeknica, an IQVIA business

medical devices

+1 305-445-2080

About

BioTeknica, an IQVIA business, is a global consulting firm specializing in engineering, quality, and regulatory services for the medical device, pharmaceutical, and biologics industries. With over 25 years of experience, the company helps clients achieve regulatory compliance, enhance product quality, and prepare for FDA inspections through a comprehensive range of consulting services. The firm offers services such as regulatory compliance, FDA inspection readiness, quality engineering, operational reviews, technical development, validation, and training sessions. BioTeknica is ISO 9001:2015 certified, reflecting its commitment to quality management. It serves a diverse clientele, including manufacturers and research organizations, focusing on building partnerships to support market success and compliance needs. BioTeknica's vision is to improve healthcare by enhancing product quality and safety. The company emphasizes core values like quality service, trust, and collaboration, fostering a professional environment that promotes growth and client satisfaction.

Technologies

Constant Contact Outlook Zendesk WP Engine WordPress.org Mobile Friendly reCAPTCHA Linkedin Marketing Solutions Salesforce Remote

Keywords

quality & regulatory compliance quality engineering validation commissioning fda inspection readiness lean quality solutions 483 warning letter consent decree resolution technical development services is it information systems management iso 9001 certified capa risk management iso 13485 21 cfr 820 data integrity cybersecurity production proces controls medical equipment manufacturing medical device manufacturing quality systems development testing laboratories and services pharmaceutical industries product validation biotech validation medical device validation regulatory gap analysis

Location

2100 Ponce de Leon Blvd, Coral Gables, Florida, United States, 33134

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