INSIGHTS ON REGULATORY COMPLIANCE
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Are You Aligned With FDA's Computer Software Assurance Methodology?
Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.
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The Ex-Regulator's View On Small Surface Contamination Control
Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. Learn about the critical steps, techniques, and validation needed to ensure product safety.
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Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2
Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.
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Navigating The Evolution Of EU Health Technology Assessment (HTA) Regulation
The future of pharmaceutical access in Europe is being shaped by the new EU HTA regulation. Insights from Pharma 2025, featuring Herbert Altmann and Alexander Natz, shed light on this pivotal shift.
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Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements6/19/2024
Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.
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How To Easily And Quickly Monitor Cleanrooms5/6/2024
Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.
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Characterizing The Effects Of Moisture On Pharmaceutical Materials12/30/2024
Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discovery SA enables humidity and temperature profiling for improved drug formulation.
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MilliporeSigma's 97-Day Implementation Success Story3/19/2025
Discover how MilliporeSigma transformed validation processes with a digital validation system to achieve efficiency and compliance in just 97 days as well as learn key takeaways from their swift transition to digital validation.
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Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics5/16/2025
All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
REGULATORY COMPLIANCE SOLUTIONS
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Many Contec wipes and mops were developed through customer requests. Explore our wipes and mops along with how we minimize the risk of endotoxin contamination of a pharmaceutical product.
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Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.
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As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.
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Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
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Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.