INSIGHTS ON REGULATORY COMPLIANCE
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Tapping Into The Unexplored Through 505(b)(2) Pathway
Leveraging the the 505(b)(2) regulatory pathway can enable an accelerated approval timeline and help advance your drug product to market. Review the three statutes that govern the approval pathways.
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The Container Closure Integrity Requirements In The Revised EU Annex 1
Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.
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Solving Biopharmaceutical Manufacturing Production Records Challenges
Solve your companies manual manufacturing production records problems with modern manufacturing execution systems and gain the competitive advantage.
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The Future Of The FDA: Operating In An “Electronic World”
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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Key Takeaways Of Annex 1: What It Means For Your Cold Chain Management10/19/2023
What are the practical implications of the latest Annex 1 update, specifically for cold chain management?
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EU GMP Annex 1: Impact On Cleaning And Disinfection3/30/2023
Explore the most recent rewrite of the EU Annex 1 document as well as the contamination control strategy outlined within.
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What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product8/11/2023
Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.
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The Importance Of 503B Facilities In Drug Manufacturing Today10/5/2023
Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.
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Nitrosamine Impurities Deadline: Are Your Products Compliant?11/6/2023
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
REGULATORY COMPLIANCE SOLUTIONS
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As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.
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Learn how to utilize enabling technologies, including instruments, informatics, and chemistry/consumables with our budget-friendly educational services.
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High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.
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We can assist in the development of necessary validation documents, including test protocols, based on current industry thinking and alignment with global regulatory authority expectations.
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Discover how our fully automated pipetting robot can help you increase repeatability and performance for both routine and complex laboratory workflows.