Category: Regulatory

Healthcare Compliance Program: Regulatory Compliance Framework A structured system created to guarantee that healthcare organizations follow relevant laws, rules, and ethical standards is known as a healthcare compliance program. A key element of these programs is regulatory compliance, which aids organizations in lowering legal risks, safeguarding patient safety, and preserving confidence with stakeholders, patients, and… Continue reading Healthcare Compliance Program: Regulatory Compliance Framework

What is Environmental Risk Assessment (ERA)? Environmental Risk Assessment (ERA) is a process applied to the identification, assessment, and control of the risks associated with the environment that are caused by human activity or natural occurrence. It can assist organizations to know the effects that their operations can have on the air, water, soil, ecosystems,… Continue reading What is Environmental Risk Assessment (ERA)?

What is a Finished Dosage Form? A Finished Dosage Form (FDF) refers to a pharmaceutical product that has gone through all stages of manufacture, processing, packaging, and labeling and is ready for distribution and administration to a patient. An FDF contains an active pharmaceutical ingredient (API) along with excipients in a predetermined form that is… Continue reading What is a Finished Dosage Form?

What Is EUDAMED? The European Union created EUDAMED (European Database on Medical Devices), a centralized database, to improve the safety, traceability, and transparency of medical devices and in vitro diagnostic (IVD) devices throughout Europe. It is an essential part of the EU’s In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR).

What Is the European Medicines Agency? The European Medicines Agency, or EMA, handles the scientific review and safety checks for medicines used by people and animals across the European Union. It’s been around since 1995 and makes sure that any medicine you find in the EU is safe, actually works, and meets strict quality standards.

What Is a Development Safety Update Report (DSUR)? A Development Safety Update Report (DSUR) is a formal safety report that is prepared by the pharmaceutical companies at the clinical development stage of an investigational medicinal product (IMP). It is aimed at ensuring that participant safety is maintained by giving an overall annual review of all… Continue reading What Is a Development Safety Update Report (DSUR)?

What Is a Dossier Submission? Dossier Submission is a systematized procedure for gathering and submitting documentations to legal bodies to seek authorization of pharmaceuticals, medical devices, or healthcare items. Such dossiers show that a product has attained the necessary standards of quality, safety, and efficacy prior to becoming marketed or distributed in a particular country… Continue reading What Is a Dossier Submission?

What Is the Drug Information Association (DIA)? A worldwide nonprofit organization, the Drug Information Association (DIA) is committed to improving healthcare by fostering collaboration and knowledge sharing among experts in the creation, regulation, and lifecycle management of pharmaceuticals and medical products.

What is NextGen ESG? In the current dynamic regulatory and sustainability environment, NextGen ESG is a clear breakthrough in the way companies approach, report, and optimize their environmental, social, and governance (ESG) practices.

What Is Dossier Authoring? Dossier authoring means pulling together all the technical documents you need for regulatory submissions in pharma, biotech, or healthcare. You lay out everything—how the product’s made, how safe it is, how well it works, all the details regulators want to see before they sign off on a drug or medical product.