Your probability of success increases the earlier and more thoroughly you prepare – our proven processes fully prepare your organization for any regulatory challenges.
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.
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How Non-Compliance Can Impact Medical Device Manufacturers—and What You Can Do to Prepare Process validation is a critical requirement for medical device manufacturers. The FDA routinely issues Form 483s and Warning Letters when companies fall short in this area, underscoring the importance of robust validation protocols. Since 2020, there have been at least 43 documented [...]
Due Diligence and Quality Systems Integration… More Important than Ever during Tumultuous Period for Pharmaceutical and Medical Device Industry Global Trade Wars … Supply Chain Interruptions … U.S. government initiatives for reshoring of manufacturing for critical Medical Device and Pharmaceutical products … these are all significant drivers for mergers and acquisitions during this period which [...]
BIOTEKNICA COMMUNITY OUTREACH Peru, Miami, Africa! When not traveling around the world for client business, BioTeknica team members can be found reaching out to local and global communities, helping to make a difference. Beautifying the Community with Habitat for Humanity Recently, 11 BioTeknica Team members and their families joined Habitat for Humanity of Greater [...]
Meet Ruben, mild-mannered BioTeknica Principal, Co-Founder, and Senior Quality Engineer. Think you know him? Think again. When you talk to clients about Ruben Capo, you hear things like he “provided the insight, expertise and leadership in leading the process validation effort,” or he “is very knowledgeable and an excellent consultant for regulatory matters.” [...]
Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their CAPA processes? How did BioTeknica help a client with an ineffective CAPA process eliminate repeat CAPAs for similar nonconformance events? The results were startling. CAPA ABCs As the “Do Re Mi song” says, [...]
Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our Subject Matter Experts (SMEs) will share their insights. Today, SME Saeid Ebrahim explains how to validate with a high degree of assurance. Please be assured that in the event of further disruptions, we are [...]
Feeling unsure of how the FDA’s updated reporting processes will affect you? You’re not alone. BioTeknica SMEs delved into the real-world impact of these new reporting programs at a recent conference. Click below to get their Top 5 MDR tips. Please be assured that in the event of further disruptions, [...]
The FDA has modified the regulations regarding adverse event reporting during a pandemic to include COVID-19. Click below for key points about the updated guidance as of March 2020. Please be assured that in the event of further disruptions, we are prepared to continue with our services remotely in a [...]
2 New Laws Impact Device Industry According to a presentation by FDA official Blake Bevill, two recent laws will impact the device industry: 1. Food and Drug Administration Re-Authorization Act (FDARA) of 2017 2. 21st Century Cures Act FDARA Highlights The FDA Reauthorization Act of 2017 (FDARA), an amendment to the Federal Food, Drug, and [...]
4 Strategies for Keeping Current In An Evolving World of Compliance At a half-day conference of the American Society for Quality (ASQ) conference whose theme was Quality is Not a Goal – It’s a Way of Life, Julie Larsen provided industry professionals essential tips and best practices to stay current as compliance trends evolve. [...]
