Global Engineering, Quality & Regulatory Consulting

Serving Manufacturers of Medical Device, Pharmaceutical and Biologics for Over 25 Years

Global Engineering, Quality & Regulatory Consulting

Serving Manufacturers of Medical Device, Pharmaceutical and Biologics for Over 25 Years

WHY BIOTEKNICA?

Because the probability of success increases the earlier and more thoroughly you prepare – and our proven methodologies fully prepare your organization for any regulatory challenge. We pride ourselves on prompt response times and our diverse and unique technical skillsets to fully service your organization.

READ MORE ABOUT OUR SERVICES

OUR VISION

We aim to improve healthcare by partnering with medical device and pharmaceutical manufacturers to enhance their product quality, safety, and effectiveness.

OUR VISION

We aim to improve healthcare by partnering with medical device and pharmaceutical manufacturers to enhance their product quality, safety, and effectiveness.

ISO 9001 CERTIFIED

Unlike most consulting firms, we are an ISO 9001:2015 certified company with global operations.

ISO 9001 CERTIFIED

Unlike most consulting firms, we are an ISO 9001:2015 certified company with global operations.

What Our Clients Are Saying About Us

“BioTeknica were real champs to complete assessments of all 11 QC lab systems in the compressed timeframe and were especially responsive in addressing questions and enlightening the site on data integrity controls.”

Director, Quality Assurance

“Very professional reporting! My team conveyed that the assessment was well done and offers us great value. Thank you BioTeknica for performing this assessment.”

Vice President, Quality & Regulatory Affairs-Medical Division
Quality Manager
Operations Excellence Change Agent
Electrical Technical Strategist
Director, Manufacturing Operations & Clinical Quality
Plant Manager

What Our Clients Are Saying About Us

“BioTeknica were real champs to complete assessments of all 11 QC lab systems in the compressed timeframe and were especially responsive in addressing questions and enlightening the site on data integrity controls.”

Director, Quality Assurance

“Very professional reporting! My team conveyed that the assessment was well done and offers us great value. Thank you BioTeknica for performing this assessment.”

Vice President, Quality & Regulatory Affairs-Medical Division
Quality Manager
Operations Excellence Change Agent
Electrical Technical Strategist
Director, Manufacturing Operations & Clinical Quality
Plant Manager

Subscribe to Our Newsletter

Select list(s) to subscribe to


By submitting this form, you are consenting to receive marketing emails from: BioTeknica, Inc., 2100 Ponce de Leon Blvd, Coral Gables, FL, 33134, https://bioteknica.com/. You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email. Emails are serviced by Constant Contact
SEND US A REQUEST