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.
Compliance is Everyone’s Concern, But It’s Our Business
Some of our well-known services include:
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’s approach was one of inclusiveness…they included our people appropriately.”
“BioTeknica is very skilled at process validation”
“Our manufacturing line was a large scope fast-paced project with an extremely tight timeline. BioTeknica did a great job training our employees on the process validation methodologies and meeting critical deadlines.”
“The flexibility of BioTeknica’s team was appreciated, as we had an evolving scope for this project as it progressed.”
“I truly enjoyed working with Julie. Wasn’t sure how it was going to go when she first showed up and announced, “I am here to help”. But she was true to her word and was a great partner. She allowed me to provide the coordination and leadership, which allowed her to focus on being the subject matter expert. She obviously has a lot of experience and helped us map out a good plan. Her feedback to the team was clear and concise. We would not have been as successful in the audit without her support.”
What Our Clients Are Saying About Us
“BioTeknica’s approach was one of inclusiveness…they included our people appropriately.”
“BioTeknica is very skilled at process validation”
“Our manufacturing line was a large scope fast-paced project with an extremely tight timeline. BioTeknica did a great job training our employees on the process validation methodologies and meeting critical deadlines.”
“The flexibility of BioTeknica’s team was appreciated, as we had an evolving scope for this project as it progressed.”
“I truly enjoyed working with Julie. Wasn’t sure how it was going to go when she first showed up and announced, “I am here to help”. But she was true to her word and was a great partner. She allowed me to provide the coordination and leadership, which allowed her to focus on being the subject matter expert. She obviously has a lot of experience and helped us map out a good plan. Her feedback to the team was clear and concise. We would not have been as successful in the audit without her support.”
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