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Labeling

Effective Communication for the Safe Use of Biosimilars

Blogs, Labeling / By

Biosimilars and interchangeability with biologics has been a topic of discussion for regulatory authorities worldwide, including their definitions and varying requirements per regions. However, a key requirement or standard for interchangeability requires applicants to provide sufficient information to demonstrate bio similarity. This reflects in the biosimilars labelling requirements where prescription drug and biological product labels …

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Advancing Healthcare through Electronic Product Information

Blogs, Labeling, Regulatory / By

Electronic Product Information (ePI) is authorized, statutory information for medicines, covering patient information leaflets and the Summary of Product Characteristics for healthcare professionals. It adheres to a semi-structured format with the common EU electronic standard, optimized for electronic handling, internet dissemination, and compatibility with healthcare information systems. Despite print options, the primary aim of ePI …

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Supporting Labelling Compliance with Searchable Databases

Blogs, Labeling / By

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 …

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Prescription-Drug-Use-Related Software

Blogs, Labeling, Regulatory / By

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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Structured Product Labeling

Structured Product Labeling

Blogs, Labeling / By

Structured Product Labeling (SPL) was first introduced in 2006 by the US Food and Drug Administration (FDA) with the aim to enhance the communication of product, quality, and facility information to label submissions. The move to the electronic Extensible Markup Language (XML) format, compared to the PDF format, has further streamlined drug label review processes, …

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