Category: Regulatory

In a digital-first healthcare ecosystem, clarity, consistency, and easy access to information about drugs are more important than before. That’s where the Structured Product Monograph (SPM) comes in a modern, structured, and machine-readable version of a traditional product monograph.

Drug information is important in highly regulated world of pharmaceuticals because use of incorrect information may result in an injurious outcome. The Structured Product Labeling (SPL) is one of the basic instruments that the U.S. Food and Drug Administration (FDA) employs in this undertaking.

What is Patient Information Leaflet (PIL)? Understanding your medication is as important as taking it correctly. One of the key tools that help patients make informed decisions about their health is the Patient Information Leaflet (PIL). Chances are, whether you are prescribed medication or purchase an over-the-counter product, it will have a PIL.

Accuracy and compliance are the key in the pharmaceutical profession and particularly when they present regulatory materials to health authorities. The simplest formatting mistake might mean rejection or subject to expensive delays. Submission eValidation guarantees that your electronic submissions are completed in all technical and structural compliance prior to sending regulators.

What is Submission Level Publishing? Regulatory submissions in the pharmaceutical industry are key processes that will dictate whether a drug or a medical product will make it to the market. In the setting of highly demanding regulatory requirements and complicated documentation, there has been the development of submission level publishing as a very important process… Continue reading What is Submission Level Publishing

The pharmaceutical industry depends on clear and precise information on medicinal products to establish their safe and effective use. The most important of regulatory documents used in this capacity is the Summary of Product Characteristics (SmPC). The document serves as the foundation of communication among pharmaceutical companies, regulatory authorities and health professionals.

Regulatory efficiency is essential in the current fast paced pharmaceutical landscape. Global Electronic Submissions have transformed the way companies have been presenting their drug applications and data to health authorities all over the world. This digital transformation, which replaces paper processes, also increases drug approval times, supports compliance, and facilitates the delivery of life-saving medications… Continue reading What is Global Electronic Submissions

What is a DUNS Number and Why Does Your Business Need One? Credibility and transparency are the secrets of success in the contemporary business environment that is characterized by global interconnectedness. Among the key instruments that contribute to the creation of both is a DUNS Number. In Masuu Global, we have realized the significance that… Continue reading What is a DUNS Number and Why Does Your Business Need One?

Nitrosamine Impurity Risk Assessment: Ensuring Product Safety and Regulatory Compliance The use of nitrosamines in pharmaceutical manufacturing has become a major topic of interest because it is considered a probable carcinogen in humans. All regulators, such as the FDA and EMA, are currently mandating manufacturers to evaluate and mitigate the risk of nitrosamine impurities in… Continue reading Nitrosamine Impurity Risk Assessment: Ensuring Product Safety and Regulatory Compliance

What is an Investigational Medicinal Product Dossier (IMPD)? A Guide to the Investigational Medicinal Product Dossier Regulatory documentation is crucial in ensuring safety and effectiveness of the new medicines in the complicated world of drug development and clinical research. The IMPD, or the Investigational Medicinal Product Dossier is one of those key documents in the… Continue reading What is an Investigational Medicinal Product Dossier (IMPD)