Quality & Compliance
Annex 11 2011 Version vs. Annex 11 2025 Draft Version: What are the Differences and Enhancements?
The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and...
Regulatory Sciences
Reclaiming the European Market: How to Secure EU/UK MAH Status Without the Local Infrastructure
For many US and APAC pharmaceutical companies, reacquiring the European rights to a successful, out-licensed product is a smart strategic move — an opportunity to capture greater margins, regain...
Quality & Compliance
How Mature Are Your Data Integrity Practices? New FDA and EU Regulatory Focus Areas
Data integrity has been in regulators' spotlight for decades, and the expectations for ensuring data integrity are evolving and increasing. This is partly because of the various Data Integrity...
Medical Information
The Shift Toward Globalization in Medical Information: How ProPharma is Helping Shape the Future in Japan
Over the past decade, the pharmaceutical industry has moved steadily toward the globalization of Medical Information (MI) services. Standard Operating Procedures (SOPs), harmonized processes, and...
Medical Information
Medical Information in the Netherlands: Safeguarding Compliance and Patient Confidence
Access to trustworthy pharmaceutical information is essential for patient safety and informed decision-making. In the Netherlands, medical information (MI) services are central to this goal,...
Regulatory Sciences
Tips for Preparing Successful FDA 510(k) Submissions
Securing FDA clearance through the 510(k) process is a critical milestone for many medical device manufacturers seeking market entry in the US. While the pathway is well-defined, many submissions...
Quality & Compliance
How to Select the "Right" CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company's needs. Every company knows timing is critical to success. But...
Regulatory Sciences
FDA Launches Crackdown on Deceptive Drug Advertising
On September 9, 2025, the US Department of Health and Human Services (HHS) and FDA unveiled a sweeping effort to clamp down on misleading direct-to-consumer (DTC) pharmaceutical advertising. The...
Regulatory Sciences
FDA to Release CRLs in Real Time: What Does This Mean for Drug Developers?
On September 4, 2025, FDA announced a sweeping policy change: the real-time release of Complete Response Letters (CRLs); a continuation of FDA's July 10, 2025 publication of previously undisclosed...
Regulatory Sciences
Transparency Requirements and the Requirement for Document Redaction
In an era of increasing scrutiny and demand for transparency in clinical research, the European Union (EU) has taken significant strides to enhance public access to clinical trial data and ensure the...
Medical Information
Balancing Efficiency and Quality in High Volume Medical Information Contact Centers
In the pharmaceutical and medical information space, contact centers serve as a vital bridge between healthcare professionals, patients, and the companies that manufacture and distribute...
Regulatory Sciences
MAH Expertise Across Eastern Europe — and Beyond
Navigating pharmaceutical regulations across multiple countries isn't just about knowing the rules — it's about understanding the rhythm of each market, responding quickly to change, and having the...
Regulatory Sciences
MLR Submission Checklist: Preparing for Speed and Compliance
Pharmaceutical, biotech, and MedTech companies invest significant time and resources into developing promotional materials, only to face avoidable delays during the Medical, Legal, and Regulatory...
Regulatory Sciences
Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS
Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...
Clinical Research Solutions
The Role of CROs in Clinical Research & Clinical Trials
Clinical trials are complex, resource-intensive, and heavily regulated endeavors that span months to years. For many pharmaceutical, biotechnology, and medical device companies, navigating this...
Quality & Compliance
FDA Inspection Readiness: Top Observations and How to Avoid a Form 483
For medical device manufacturers, FDA inspections are a critical component of regulatory oversight and quality assurance. Whether part of a routine surveillance program, pre-approval inspection, or...