INSIGHTS ON REGULATORY COMPLIANCE
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![Screenshot 2025-03-27 073515]( "Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent It")
Do Not Bear Cross Contamination In The Pharmaceutical Industry – Prevent ItLearn how thorough cleaning and process optimization in pharma manufacturing prevent cross-contamination, ensure product integrity, and enhance efficiency while also improving compliance and reducing costs.
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![02 West]( "Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics")
Essential Drug Delivery Outputs For Devices To Deliver Drugs, BiologicsAll future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.
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![standardization certification compliance-GettyImages-1733514056]( "Move Beyond Manual CQV Challenges With Digital Solutions")
Move Beyond Manual CQV Challenges With Digital SolutionsReview how digitalizing commissioning, qualification, and validation (CQV) with a new software streamlines processes, enhances compliance, and reduces time to drive efficiency and sustainability.
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![EU GMP Annex 11 Action Plan: Assessment, Strategy And Digital Solutions For Compliance]( "EU GMP Annex 11: Compliance Strategy And Digital Solutions")
EU GMP Annex 11: Compliance Strategy And Digital SolutionsExplore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.
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Kneat Solutions Bio-Expo Live February 2025: Quality, Data, And Analytical Solutions3/17/2025
Discover how top pharma companies streamline validation, reduce cycle times by 40%+, and ensure compliance with a digital validation platform that also aids in real-time reporting and compliant testing.
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Implementing A Risk-Based Approach To Calibration2/20/2024
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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Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation9/17/2025
Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
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How Digital Cleaning Validation Can Simplify Audit Readiness And Improve Compliance9/26/2025
Discover how to enhance audit readiness and improve compliance by shifting to a digital cleaning validation program. Learn to determine worst-case products and maximum safe carryover limits.
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How Digital Procedures And E-Logbooks Are Transforming Manufacturing9/2/2025
Paper-based processes slow down life sciences manufacturing and introduce compliance risks. Discover how digital procedures and electronic logbooks can boost accuracy, speed, and traceability.
REGULATORY COMPLIANCE SOLUTIONS
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![Regulatory compliance Getty Images-1256156511]( "Quality, Compliance, And Regulatory Services For Life Sciences")
The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
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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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![GettyImages-950086574-microscope-scientist-pill-development]( "Developing Pediatric Formulations")
From safety considerations to kid-friendly dosing, we can help you get your pediatric formulation right.
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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-640168692-laboratory-equipment-tablet-quality]( "Addressing Your Requirements For Parenteral Applications")
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.
