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Author name: development

Drug-device registration in CIS countries

Case Studies, Regulatory /

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

Blogs, Regulatory /

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

Blogs, Labeling, Regulatory /

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

News and Events /

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

Insights, Regulatory /

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

News and Events /

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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UK MHRA International Recognition Procedure

Blogs, Regulatory /

The UK MHRA’s Latest Update on the International Recognition Procedure Introduction The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has taken a significant step towards enhancing its regulatory processes. The reason behind this step is to facilitate medicine access by expediting their approval. The MHRA has recently released comprehensive guidance on

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How does EMA use Artificial Intelligence and Large Language Models in Medicine Regulation?

Insights, Regulatory /

Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke, Executive Director of the European Medicines Agency. Introduction Artificial Intelligence (AI) is revolutionizing the regulation of medicines by offering innovative solutions to enhance drug safety, efficacy, and overall patient well-being. With its ability to process vast amounts of data, identify patterns, and predict potential risks,

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Formal Meetings for Biosimilar Product Development with the US FDA

Blogs, Medical Writing /

Comprehending the Key Components of Formal Meetings for Biosimilar Development with the FDA Introduction The development and approval process for biosimilar or interchangeable biosimilar product development is a complex journey. It requires close collaboration between pharmaceutical companies and global regulatory consulting authorities. In the United States, the Food and Drug Administration (FDA) plays a pivotal

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