quality compliance

Woman in hairnet holding laptop investigating machines

Quality & Compliance

GxP Readiness and Auditing: Your Quality System’s Insurance Policy for Compliance Systems

In the world of pharmaceuticals, biotech, and medical devices, maintaining compliance with Good Practices (GxP) is critical to ensuring product safety, efficacy, and quality. But how do companies...

Regulatory Sciences

Navigating the Nordic Pharmaceutical Landscape: Key Considerations for a Successful Launch

The Nordic region, renowned for its world-class healthcare, presents unique opportunities and challenges for pharmaceutical companies. Understanding the Nordic pharmaceutical landscape is crucial for...

Quality & Compliance

Diary of Compliance: A Year in the Life of Ensuring FDA CAPA Standards

Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes...

Person in lab coat investigating a medical device

Quality & Compliance

What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance

Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked...

Quality & Compliance

EU Pharmaceutical Legislation Revisions FAQ

On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following...

Health care professionals reviewing computer monitors inside an examination room

Quality & Compliance

Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing

Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...

Quality & Compliance

Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development

In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...

Group of medical professionals smiling in a common area

Quality & Compliance

Staying GMP Compliant: A Consultant's Guide to Compliance Bliss

Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...

Lab technician wearing hairnet mask and scrubs looking into microscope

Quality & Compliance

Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide

Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...

Person wearing protective equipment reviewing a tablet device

Quality & Compliance

15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific...

1 2 3 4 5