INSIGHTS ON REGULATORY COMPLIANCE
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Navigating Cleanroom Compliance For Safe Material Transfer
Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.
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The Crucial Role Of Cleaning In Effective VPHP Decontamination For Isolators
Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.
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Implementing A Risk-Based Approach To Calibration
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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How Non-Destructive Headspace Analysis Advances CCI Testing
Opting to use headspace analysis to assess container closure integrity (CCI) for your drug packaging ensures robust data and CCI assurance to protect your product and maintain regulatory compliance.
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Overview Of Biological Indicator And Sterilization Monitoring Systems7/2/2024
Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.
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Unlocking Digital Transformation: Embrace CSA For Rapid Innovation7/16/2025
Gain valuable insights from industry leaders on how life sciences manufacturers can embrace innovation and digital transformation through the FDA’s CSA guidance.
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Analytical Strategies To Address Common Development Challenges4/30/2024
Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.
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How To Get Products To Patients Faster With A Connected QMS8/14/2025
BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.
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Optimizing Contamination Control: Strategy Planning And Execution7/25/2025
A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.
REGULATORY COMPLIANCE SOLUTIONS
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Pharmaceutical manufacturers face many challenges, from safeguarding brand reputation and protecting consumers' welfare to complying with legislative and regulatory standards.
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Ensure patient safety and product efficacy with high-quality pharmaceutical excipients that are designed to streamline regulatory approval and support sterile liquid drug formulation development.
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As your personal partner and pharma consulting expert, we sincerely understand the specific process and regulatory challenges of pharmaceutical, biotech, and medical device manufacturers in detail.
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MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable.
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A clear path to global regulatory submissions.