INSIGHTS ON REGULATORY COMPLIANCE
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![iStock-1275682432-inspection-regulatory]( "cGMP vs GMP: What’s The Difference?")
cGMP vs GMP: What’s The Difference?Understand the differences between GMP vs cGMP, how cGMP lays the foundation for product quality, and how it impacts new drug development and manufacturing for your pharmaceutical.
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![Aji-HighPotency]( "High Potency Fill Line")
High Potency Fill LineWhether it's a liquid or lyophilized product, we provide capacity, quality, and expertise to ensure a stable supply of your promising therapeutics.
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![fda]( "The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance")
The Role Of FDA Predicate Rules In 21 CFR Part 11 ComplianceExplore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization.
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![iStock-1155553590-syringe-glove-doctor-vaccine-medicine]( "Overcome Vaccine Development Complexities With The Right Supply Chain Partner")
Overcome Vaccine Development Complexities With The Right Supply Chain PartnerExplore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.
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Reasons To Buy Into A Joint Auditing Program5/26/2022
Learn how you can save costs and time by having access to licensable joint audit reports.
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Leveraging 505(b)(2): Real-World Evidence Rescues Program8/8/2022
Discover how a biotech company was assisted who could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA.
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The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management6/22/2022
This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.
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Biosimilars: Evolving Challenges And Considerations1/11/2021
Evolution of the biosimilar regulatory pathway will require manufacturers to ask critical questions about the implementation of legacy and novel technologies and procedures in downstream processing.
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Pediatric Dosage Forms: Reformulation And Development Expertise1/20/2022
Infrastructure and expertise cover the sweet spot for producing the small-to-midsize batches needed to meet industry demands for PDFs and orphan drugs, and also extend to large-scale manufacturing.
REGULATORY COMPLIANCE SOLUTIONS
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![Data Electronics]( "eCTD Submissions And Registrations Software")
MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.
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![GettyImages-1096502334-lab-microscope-research]( "R&D And Analytical Services")
Our team of analytical experts provide experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
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![Knowledge training skills education GettyImages-1283533232]( "Increase Employee Retention And Compliance By Investing In Quality Training From Waters")
Learn how to utilize enabling technologies, including instruments, informatics, and chemistry/consumables with our budget-friendly educational services.
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![Intelligent Automation AI]( "Pharmaceutical Automation & Information Technology Services")
As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.
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![CAI]( "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.
