FEATURED POST
TO YOU, FROM US
The COVID-19 pandemic has hurled us all into uncharted territory. We question our collective truths; wonder who we are as a nation; ponder our priorities, how we take care of one another, stay healthy, keep our businesses afloat, teach our children, support our heroes, and lift our most vulnerable, all while attempting to keep our anxieties in check. Together we grapple with these questions as a nation, small communities, and as businesses, families, and individuals.
Operational Review
Operational Review & Optimization for Medical Device and Pharmaceutical Companies Cost Reduction Strategies Business Process Re-engineering (BPR) Process Optimization/Improvement Process Control [...]
S3 Method – Simple, Systematic, Sustainable
S3 Method: Simple, Systematic, Sustainable Can You Be Compliant While Keeping Costs Down & Positively Impacting Your Bottom [...]
Quality Engineering
Quality Engineering Are you able to resolve the root cause? Quality Engineering services using proven methodologies to [...]
Regulatory Services
Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory support for [...]
FDA Inspection Readiness
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare for your [...]
Regulatory Compliance
Regulatory Compliance We not only know what to do but – how to do it. We ensure that [...]
Lean Quality Solutions
Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, offers comprehensive lean [...]
Critical Issue Management
Critical Issue Management for FDA 483 Warning Letters, Recalls & Safety Alerts Agency Representation & [...]
Operational Review
Operational Review & Optimization for Medical Device and Pharmaceutical Companies Cost Reduction Strategies Business Process Re-engineering (BPR) [...]
S3 Method – Simple, Systematic, Sustainable
S3 Method: Simple, Systematic, Sustainable Can You Be Compliant While Keeping Costs Down & [...]
Quality Engineering
Quality Engineering Are you able to resolve the root cause? Quality Engineering services [...]
INDUSTRY NEWS ROUNDUP
Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled for June 2020 in Phoenix, AZ, has [...]
SUCCESS STORIES Bringing an Inadequate CAPA Process to Effectiveness
Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their CAPA processes? How [...]
ASK A BIOTEKNICA SME HOW TO VALIDATE A PROCESS WITH A “HIGH DEGREE OF ASSURANCE” AND WHAT DOES THAT EVEN MEAN?
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 [...]
ASR IS OVER! HOW DO VMSR & NEST IMPACT YOUR ORGANIZATION?
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 [...]
KEY FDA EXPECTATIONS FOR ADVERSE EVENT REPORTING DURING A PANDEMIC
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 [...]
BIOTEKNICA OPERATING AT FULL CAPACITY Company Implements Business Continuity Plan During COVID-19 Crisis
BioTeknica and its sister companies, Qualified Data Systems and Synergis, are here for you. We are open and operating at full capacity with the [...]