Quality & Compliance
Adapting Technology Transfer Strategies in Pharmaceutical Manufacturing Amidst New Tariff Regulations
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...
Quality & Compliance
Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...
Quality & Compliance
Navigating the Transition from ICH E6 (R2) to (R3)
Ensuring Compliance with ProPharma's Expert Support The global regulatory landscape for clinical trials continues to evolve to keep pace with technological advancements, risk management, and the...
Quality & Compliance
Staying Ahead: Why BIMO Inspection Readiness Audits Are Essential for Clinical and Biological Research Compliance
In the world of clinical and biological research programs, ensuring compliance with regulatory standards is not only essential for maintaining the integrity of studies but also for safeguarding the...
Pre-Approval Inspection (PAI) Readiness is Easy, Right?
Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with...
Quality & Compliance
WHO Issues Guidance on Antibiotic Pollution Control
On September 3, 2024, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste...
The Evolving Landscape of Quality Management Systems in the Life Sciences Industry
In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of...
Quality & Compliance
Breaking the Chains of Project Management Dysfunction
Right now, you are sitting in front of your computer and wondering how, based on current project status, you will achieve your remaining project goals for the year or achieve those planned for the...
Quality & Compliance
Meet the Expert: Andrew Bright
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
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...
Quality & Compliance
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...
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...
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...