INSIGHTS ON REGULATORY COMPLIANCE
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![Chrom-Campaign-Key-Visual-Overall-Resolute-BioSC-B]( "Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological Cleaning")
Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological CleaningIssues related to cleaning and cleaning validation are some of the most common concerns that arise in FDA Warning Letters. Discover how to ensure you pass your cleaning validation tests.
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![Software Validation GettyImages-1357020474]( "Computer Software Assurance: A Game-Changer For Life Sciences Compliance")
Computer Software Assurance: A Game-Changer For Life Sciences ComplianceCSA offers a smarter, risk-based approach to software validation that reduces documentation burdens while enhancing product quality. Learn how teams are using it to accelerate digital transformation.
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![Virus Filtration]( "Virus Filtration: Regulations And Mechanisms")
Virus Filtration: Regulations And MechanismsIn this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.
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![Scientists Mixing Solution In Lab GettyImages-1443286944]( "How To Overcome Common Single-Use Assembly Design Challenges")
How To Overcome Common Single-Use Assembly Design ChallengesSingle-use systems offer major benefits in pharma manufacturing, but design complexity brings challenges. Learn how to overcome issues like scalability and quality assurance with integrated strategies.
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Navigating The Digital Frontier5/15/2024
This panel discussion looks ahead at decentralized manufacturing, key regulatory considerations, and the anticipated future where cybersecurity becomes a paramount focus.
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Electronic Batch Reporting1/22/2024
Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.
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Navigating Your Holistic Approach To CCI For Biologic Drug Products6/12/2024
Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.
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Remote Regulatory Assessments Q&A2/20/2024
Explore what Remote Regulatory Assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of non-compliance.
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Biotech's Plastic Problem Meets Its Match8/8/2025
Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.
REGULATORY COMPLIANCE SOLUTIONS
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![TouchTools™]( "Programming Simplicity And Operational Consistency At Your Fingertips")
Streamline your lab automation with a customizable touchscreen, dynamic programming, and real-time monitoring to boost productivity, minimize errors, and integrate data across workflows.
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![CAI logo 2024]( "Pharmaceutical Asset Management & Reliability Services")
Asset Management & Reliability (AMR) focuses on preserving asset functions. These functions are determined by our clients’ business strategy. The focus is on producing products that conform to consumer needs in the most efficient and cost-effective manner. While conditions vary, the common factor with manufacturing process is reliability. We help our clients determine which best practices are applicable in your industry and how best to deploy them.
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![Skyland PIMS]( "Biopharma Manufacturing Process Data Made Simple")
PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful
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![Fast, Compact Absorbance Microplate Readers - SpectraMax ABS and ABS Plus Absorbance ELISA]( "Fast, Compact Absorbance Microplate Reader For a Wide Range Of Assays")
Filterless readers provide consistent results with steady temperature regulation
The SpectraMax® ABS and ABS Plus absorbance microplate readers provide the flexibility, sensitivity, and convenience for a wide range of assays such as ELISAs, microbial growth, and protein quantitation. Both readers feature an 8-channel read head for fast reads and a subset feature, the temperature independent PathCheck sensor that automatically normalizes and ensures accurate absorbance values by detecting pipetting errors. Combined with a wide application base, industry-leading SoftMax® Pro Software and validation tools, these readers fit in every lab and every budget.
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![GettyImages-1927881398-consulting-office-computer-windows]( "Computerized System Validation Services")
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.
