INSIGHTS ON REGULATORY COMPLIANCE
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![Fireside Chat]( "The FDA Modernization Act is Signed Into Law. Now What?")
The FDA Modernization Act is Signed Into Law. Now What?Scientists worldwide celebrated the signing of the FDA Modernization Act into law. Gain expert insights into what to anticipate regarding using New Approach Methods (NAMs) in novel IND submissions.
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![GettyImages-1302454470 drug review]( "Translating Study Reports – A GLP Draft Guidance")
Translating Study Reports – A GLP Draft GuidanceThe FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.
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![Part 2 Overview]( "Validation Of A Sterilization Process: Part 2")
Validation Of A Sterilization Process: Part 2Gain essential insights into sterilization processes by exploring the Overkill method—an approach that ensures product safety through rigorous cycle development and validation.
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![Dry Powder Media Manufacturing Grand Island Expansion]( "Dry Powder Media Manufacturing Grand Island Expansion")
Dry Powder Media Manufacturing Grand Island ExpansionTake a video tour of our newly expanded dry powder media manufacturing facility in Grand Island, New York. The expansion has added more than 45,000 square feet of Animal Origin Free (AOF) manufacturing space to help meet increasing global demand.
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A Compact, Flexible, And Easy To Use Benchtop Mixer11/4/2025
Compact, flexible, and easy to use, this benchtop mixer supports volumes from 100 mL to 10 L with integrated sensing options and GxP-compatible software, ideal for efficient, reproducible mixing.
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Reduce Batch Failure Risk With An Innovative Platform6/11/2025
Enhance reliability in cell therapy manufacturing with an innovative platform. Discover how the closed system and automation reduce operator errors through smart monitoring, pre-checks, alarms, and detailed batch reporting.
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Why Perform A D-Value Study? Reference Review10/31/2024
Understanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.
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Shaping The Future Of Process Intensification With Digital Solutions10/3/2025
Discover how automation, analytics, and AI are driving smarter process intensification and enabling a shift toward connected, continuous manufacturing.
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Operational Readiness In Pharma9/9/2025
Operational Readiness bridges project delivery and GMP manufacturing to ensure systems and teams are prepared for execution. Discover how a digital validation platform streamlines this transition.
REGULATORY COMPLIANCE SOLUTIONS
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![Scientist laboratory ipad iStock-1207515232]( "FDA 21 CFR Part 11-Compliant Software")
Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
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![Doctor-Comforting-Patient-GettyImages-157718473]( "Clinical Pharmacology Services")
With over 30 years of proven experience, we provide comprehensive clinical pharmacology services, from data management and analysis to the generation of clinical study reports.
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![Compliance-virtual-diagram-GettyImages-1370928101]( "Annex 1 Pharmaceutical Container Closure Integrity Testing Requirements")
As the governing regulatory document of the European Medicines Agency (EMA), EU GMP Annex 1 discusses a full host of concepts related to manufacture of sterile medicinal products. In contrast to guidance documents issued by the FDA, EU GMP Annex 1 is interpreted as law, requiring strict adherence to the regulatory expectations contained, numerous of which allude to container closure integrity testing. In fact, current proposed and ongoing revisions increase the expectations of scrutiny on package integrity.
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![LSC-Media-for-VV]( "HyClone™ Cell Culture Media For Viral Vector Production")
Whether you're looking to boost performance, enhance your capabilities, or simply get consistent, high-quality results, HyClone™ peak expression medium and HyClone™ prime expression medium are the solutions for you.
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![Solutions For Injectables]( "Solutions For Injectables And Parenteral Formulations")
Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.
