DDReg is thrilled to announce its successful nomination for the India 5000 Best MSME Awards 2023. The awards are more than just honours. They provide a platform to Micro, Small, and Medium-Sized Businesses (MSMEs), to showcase their commitment to excellence and professionalism. The nomination of DDReg for the India 5000 Best MSME Awards 2023 demonstrates […]
DDReg nominated for India 5000 Best MSME Awards 2023 Read More »
Biopharmaceutical product labelling is a multifaceted undertaking that spans various products and markets, encompassing diverse formulations and dosages. The challenge lies in consistently upholding pharmaceutical labelling compliance throughout this intricate process. Ensuring pharmaceutical labelling compliance involves following regulatory requirements and guidelines when developing and updating product labels, such as Summary of Product Characteristics (SPC), Patient
Supporting Labelling Compliance with Searchable Databases Read More »
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
Swissmedic: The Importance of Real-World Evidence in Regulatory Decision Making Read More »
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
Modernization of Cosmetics Regulation Act Read More »
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
Ensuring Safe Use of Medical Devices in Healthcare Facilities Read More »
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
Drug-device registration in CIS countries Read More »
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
Evaluating the need for comparative clinical efficacy studies in biosimilar development Read More »
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
Prescription-Drug-Use-Related Software Read More »
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
DDReg Shortlisted for ‘Regulatory’ by CPHI Pharma Awards 2023 Read More »
During an inspection, the US FDA may detect that the manufacturer has violated a significant number of regulations. These could be low-quality manufacturing processes, issues regarding product claims, and even incorrect directions for use. In this case, the FDA notifies the manufacturer of the same by way of a Warning Letter which, in addition to
Requesting Post-Warning Letter Meetings Read More »
