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.
Regulatory Sciences
Decoding FDA’s Recent Advertising Enforcement Actions
The Agency’s Advertising Enforcement Letters Reveal Shifting Regulatory Priorities On Tuesday, September 16, 2025, FDA posted 40 Untitled Letters and 8 Warning Letters directed at prescription drug...
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...
Quality & Compliance
Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths
The Crossroads of Global Compliance For medical device and diagnostic companies operating in today’s global marketplace, success depends on more than just innovative products — it hinges on a...
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...
Quality & Compliance
Why Project Management Is Essential, NOT a Luxury, for Today's Pharma Activities
When we meet with life sciences clients (especially small/mid-sized companies), Project Management (PM) is very rarely an area of importance. It is almost consistently an afterthought. Clients are...
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...
Medical Information
Why MI Experts Can Reduce Operational Burden for Pharma Companies
In today's highly regulated pharmaceutical industry, Medical Information (MI) services are expected to do more than respond to inquiries; they must provide accurate, balanced, and scientifically...
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...
Pharmacovigilance
Selecting a PMPV Vendor, Part II: Building on a Strong Foundation
Previously, we outlined the critical components to be considered when starting a clinical trial program (Safety Services: A Critical Component of Clinical Trials). In this second installment we'll be...
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...
Regulatory Sciences
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...
FSP Solutions
Recruitment Strategies in FSP: Building Agile Teams to Drive Clinical Success
Staffing has become one of the most critical and complex challenges in the success of Functional Service Providers (FSP) within clinical research. Whether you're launching a global Phase III study or...
