Pharmaceutical

Clinical Laboratory Improvement Amendments (CLIA) is a set of laws and regulations that are designed to ensure that all laboratory testing is performe

Welcome to our guide on transitioning your medical devices to Europe’s New Medical Device Regulation (MDR)! This guide will provide an overview

The success of any business in the pharmaceutical industry relies heavily on its ability to navigate the ever-changing regulations that are required f

This guide is designed to help organizations understand and comply with the nitrosamine regulations related to marketing applications for new drug pro

Australia is home to world-class medical research, and clinical trials are a major part of this. Clinical trials are federally regulated studies that

Decentralized clinical trials (DCTs) are a new approach to conducting clinical research that shifts the traditional model in significant ways.

Good pharmacovigilance practices (GVPs) are procedures used to protect the safety of patients taking medications.

NDSRI stands for Non-selective Dopamine Reuptake Inhibitor and is a type of medication used to treat depression and other mental health conditions.

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In the current digital age, data integrity has become increasingly important as organizations strive to transition into a more automated and efficient

A smart goal is an acronym for Specific, Measurable, Achievable, Relevant and Time-bound. It is an effective method used by many organisations to ensu

The UDI System, short for Unique Device Identification System, is a system used to identify medical devices through the use of labels, barcodes, or ot

The pharmaceutical industry plays a critical role in the health and wellbeing of millions of people all over the world.

Design verification and design validation are processes used in the production of medical devices.

Quality by Design (QbD) is an approach to drug development and manufacturing that focuses on optimizing the quality of the final product by understand

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Pharmaceutical contract manufacturing helps businesses meet the increasingly complex demands of the industry.

Clinical trials are essential for medical research and have proven to be a key element in advancing medical treatments and developing new drugs.

Today, the world of pharmaceuticals is becoming increasingly complex. With global health concerns rising to the forefront, pharmaceutical companies ar

Today, the world of pharmaceuticals is becoming increasingly complex. With global health concerns rising to the forefront, pharmaceutical companies ar

Good Manufacturing Practice (GMP) is a set of guidelines, established by the World Health Organization (WHO), that focus on pharmaceutical manufacturi

Design Controls are an essential part of designing and developing any medical device. They help to ensure the safety, effectiveness and quality of a p

Risk management is an essential part of any business, and medical device startups are no exception. Without effective risk management, medical device

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Keeping sensitive data and private information secure is extremely important as well as complex

21 CFR Part 11 outlines the FDA’s requirements for the integrity, quality, and compliance of digital documents and also signatures.

It has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen.