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We’re a consulting firm specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the medical device, biological, and pharmaceutical industries.
New FDA Communications Guidelines For Inspections Medical device companies have new FDA contacts and new guidelines to communicate with the FDA regarding their inspections. Find your division and contacts and learn more about the guidelines. The Office of Medical Device and Radiological Health Operations (OMDRHO) provides advice to the Office of Regulatory Affairs (ORA) [...]
Modernizing the FDA Workforce A strategic priority identified by the FDA earlier this year is to strengthen the FDA’s scientific workforce by investing in the scientific and clinical expertise of its staff. To keep up with the complexity of modern devices and improve efficiency, the FDA is investing in enhancing the scientific and [...]
BioTeknica is an ISO 9001:2015 Certified Company BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, for its Quality Management System. Life science manufacturers can further benefit from the knowledge that every engineer, scientist and team member throughout our organization is responsible for delivering innovative customer-focused engineering and regulatory [...]
