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Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making

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Real-World Evidence (RWE) refers to clinical evidence derived from real-world data (RWD) collected outside of traditional clinical trial settings. The significance of RWE in regulatory decision making has been growing worldwide due to its potential to provide valuable insights into the safety, efficacy, and effectiveness of therapeutic products. While traditional clinical trials remain the gold […]

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Modernization of Cosmetics Regulation Act

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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant milestone in the regulation of cosmetic products in the United States. This comprehensive legislation, enacted to enhance consumer safety, imposes a series of requirements and obligations on cosmetic companies, facilities, and responsible persons within the industry. MoCRA not only expands the authority of

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Ensuring Safe Use of Medical Devices in Healthcare Facilities

All Category, Blogs, Medical Device, Pharmacovigilance /

The safe and effective use of medical devices in healthcare facilities is not merely a matter of convenience; it is a moral obligation. The welfare of patients and the quality of healthcare services depend on the responsible use of these devices. Accidents involving medical devices can have dire consequences for patients. These accidents may result

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Drug-device registration in CIS countries

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Customer Requirement: A global Non-profit organization in the area of female health & wellness wanted to obtain drug device registration and market authorization for their contraceptive that included its administration device, in CIS region, including Azerbaijan, Kyrgyzstan and Tajikistan.  The contraceptive was classified as a drug-device combination product for which regulations are challenging to navigate

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Evaluating the need for comparative clinical efficacy studies in biosimilar development

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Introduction Long-term safety, efficacy, and immunogenicity data of licensed biosimilars do not raise concerns. State-of-the-art analytical and functional testing, as well as robust pharmacokinetic (PK) and pharmacodynamic (PD) studies are sufficient to demonstrate biosimilarity. In in-vivo animal studies and large confirmatory efficacy and safety studies are generally not needed. This blog provides and overview on

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Prescription-Drug-Use-Related Software

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Introduction With the advancement in digital technology, the development of prescription drug use-related software has surged, offering innovative solutions to enhance patient care, monitor drug adherence, and improve healthcare outcomes. The U.S. Food and Drug Administration (FDA) recognized the need to address software outputs related to prescription drugs and combination products. Prescription drug-use-related software is associated

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DDReg Shortlisted for ‘Regulatory’ by CPHI Pharma Awards 2023

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DDReg is thrilled to announce that it has made it as a finalist for the CPHI Pharma Awards 2023. With 12 categories and 180 submissions, DDReg was shortlisted under the ‘Regulatory’ category for its entry on Technology-Enabled Regulatory Services through Vitalic®.   Indeed, this is a testament to DDReg’s commitment  towards regulatory excellence and innovation. Read about

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Navigating Drug Manufacturing Inspections

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The US FDA conducts drug manufacturing inspections for facilities to ensure they are compliant with the Current Good Manufacturing Practice (cGMP) standards. However, navigating through these inspections requires a clear and comprehensive understanding of several aspects. These include applicable manufacturing standards, site selection model, 483 forms, and how the FDA reviews the inspections and outcomes.

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DDREG & OKTANE HR – Training and Development Program for Employees

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DDReg took a significant stride toward nurturing its team’s potential by partnering with Oktane HR. Following the success of the ‘High Impact Manager Program’ held earlier, in June, DDReg & Oktane HR partnered once again to elevate the leadership and growth capabilities. This session was carefully curated for the next in-lines and was led by

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