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

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

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

The Role of Regulatory Labeling Regulatory labeling regulations play a crucial role in ensuring the safe and effective use of drug products by patients. However, compliance with these regulations can be complex, especially with the introduction of new requirements and updates. Global and Regional Regulatory Labeling Managing global and regional labeling in the

Dossplorer - Revolutionizing Regulatory Affairs In the fast-paced world of pharmaceuticals, navigating the complexities of regulatory affairs can be daunting. However, with the right tools and solutions, pharmaceutical companies can streamline their processes, save time, and reduce costs significantly.The RSIDM 2024 forum highlighted a crucial focus on improving and optimizing organizational processes and

Robotic Process Automation in Life Sciences Robotic Process Automation (RPA) is a technology that allows organizations to automate repetitive, manual tasks with software robots. In the field of life science publishing and submissions, RPA can be used to streamline and optimize the process of submitting research findings and regulatory documents to various regulatory agencies

Closing Remarks Sharing the Key takeaways for the Regulatory Informatics Track by Michiel Stam Celegence/Qdossier participated as exhibitors and speakers during this year’s Regulatory Submissions, Information, and Document Management Forum (RSIDMF) from February 13-15, 2023, in Bethesda, Maryland. Celegence Presentations, Short Courses & Other Contributions throughout the forum included the following: Short Course: On

IDMP Process Optimization - Webinar Transcript with Wim Cypers Wim Cypers has a long-standing experience in converting business requirements into application functionality and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues. For