The Latest on IDMP Implementation: How New Standards Are Reshaping Pharmaceutical Operations

In a recent webinar titled "Navigating IDMP Implementation: Strategies for Success" Regulatory Affairs Experts Sowmya Raju and Michiel Stam offered a clear and informative overview. Discussing the essential elements of IDMP standards and their practical implementation through the Product Lifecycle Management (PLM) portal and highlighting their impact on the pharmaceutical industry’s regulatory landscape.

2024-04-23T10:12:53+00:00April 23rd, 2024|

Search Regulatory Dossier Metadata & Content with Ease using PowerSearchâ„¢ – A Dossplorerâ„¢ Regulatory Submission Management Feature

Search Regulatory Dossier Metadata & Content with Ease using PowerSearch™ - A Dossplorer™ Regulatory Submission Management Feature  Regulatory dossiers contain comprehensive and detailed information about pharmaceutical products. Since they serve as the primary source of truth for regulatory agencies to assess the safety, quality, and efficacy, they play a crucial role in

2024-04-23T09:44:18+00:00April 19th, 2024|

Strategies for Successful Post-Market Clinical Follow-Up (PMCF) under EU MDR: Insights from a Comprehensive Webinar

In a recent webinar titled "Strategies for Successful PMCF under EU MDR: Unlocking the Mystery," medical device industry experts Smridula Hariharan and Parvathi Nambiar engaged in an illuminating discussion. They explored cost-effective PMCF strategies, discussed how to adeptly address Notified Body comments, and presented real-world case studies to illustrate successful PMCF implementations. Access

2024-04-22T17:18:59+00:00April 19th, 2024|

RAPS Euro Convergence 2024

RAPS Euro Convergence 2024 Join Celegence as we showcase our pioneering advancements at the upcoming RAPS Euro Convergence. Explore our exhibition at stand B12, where we will unveil our latest tech-enabled, AI-infused solutions and share our unparalleled expertise, designed to streamline regulatory processes, minimize expenses, and elevate compliance standards. Discover the innovation

2024-04-18T15:58:11+00:00April 18th, 2024|

Presentation of QC Samples and their Accuracy and Precision in Regulated Bioanalytical Reports

Exploring Quality Control Samples Quality control (QC) samples are an essential aspect of bioanalysis. When conducting bioanalytical studies, it is critical to ensure the accuracy and precision of the methods used to analyze study samples. One way to achieve this is by using QC samples. Samples of known concentrations or purities are

2024-04-17T12:22:13+00:00April 17th, 2024|

The Synergy Between Regulatory Intelligence and Pharmacovigilance

Ensuring Compliance and Patient Safety In the ever-evolving landscape of life sciences and healthcare, regulatory intelligence (RI) and pharmacovigilance (PV) play critical roles. Companies face multifaceted challenges that span across regulatory compliance, safety monitoring, and strategic decision-making. This is where experts like Celegence and Soterius come into play to bridge the gap

2024-04-10T13:58:54+00:00April 10th, 2024|

FDA Guidance: Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products

Navigating Annual Reportable Labeling Changes for Nonprescription Drug Products: FDA Guidance Explained Introduction In the realm of nonprescription drug products, even minor labeling changes require careful consideration and documentation to ensure regulatory compliance and consumer safety. The Food and Drug Administration (FDA) has released comprehensive guidance to assist applicants of approved new

2024-04-08T12:47:31+00:00April 8th, 2024|

AI-Powered Solutions for Regulatory Compliance in the Medical Device Industry

Harnessing AI for Regulatory Compliance In the fast-evolving landscape of the medical device industry, harnessing the power of Artificial Intelligence (AI) is not just advantageous but essential for maintaining regulatory compliance. At Celegence, we recognized the potential of AI to streamline complex processes and enhance efficiency in areas such as writing

2024-04-11T11:07:45+00:00April 5th, 2024|

Transform Your Pharmacovigilance Medical Writing

Pharmacovigilance Medical Writing In the dynamic landscape of drug development, meticulous documentation plays a pivotal role in securing regulatory approvals. Regulatory medical writing, a specialized discipline, bridges scientific insights with compliance requirements. Celegence, a leading regulatory affairs consultant, assists pharmaceutical companies in creating robust, submission-ready documents. Global Team of Medical Writing Specialists

2024-03-27T14:57:01+00:00March 27th, 2024|

Streamline Your MDR & IVDR Document Creation with CAPTISâ„¢

Streamline Your MDR & IVDR Document Creation with CAPTISâ„¢ In the intricate world of medical device and in vitro diagnostic regulations, meticulous documentation is paramount. Celegence provides cutting-edge technology solutions tailored to assist medical writers, reviewers, and managers in improving compliance and efficiency. How CAPTIS Can Streamline Your Document Creation For Medical Writers:

2024-03-26T16:01:18+00:00March 26th, 2024|
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