January 2025 Monthly Newsletter

We are delighted to welcome Shawn Bates as our new Chief Revenue Officer. With 25 years of leadership experience in the Life Sciences industry, he brings a wealth of expertise in commercial and operational strategy.

PLG is thrilled to announce the acquisition of Stragen Services, a leading European Specialty Generics platform backed by the healthcare-focused private equity firm ARCHIMED.

This strategic acquisition enhances PLG’s capacity to expand in critical areas across the French and European markets, reinforcing our commitment to delivering innovative solutions and driving growth in the life sciences sector.

The International Recognition Procedure (IRP), effective from January 1, 2024, allows to streamline their marketing authorization applications in the UK, enhancing efficiency and cost-effectiveness by reducing the submission burden and facilitating integrated approvals.

Pharmacovigilance (PV) faces growing challenges with increasing drug safety data. AI and automation offer transformative solutions to enhance efficiency, accuracy, and patient safety by improving adverse reaction detection and prevention.

Explore the critical aspects of building a strong LSO program, from mitigating risks and challenges to ensuring successful implementation. Understand key vendor considerations and best practices for long-term success.

Xavier Duburcq, CEO of ProductLife Group, recently attended the prestigious JPMorgan Conference in San Francisco, joined by Joanne Sullivan, Tanya van der Wall, and Halloran colleagues at the Biotech Showcase.

Drug Master Files (DMFs) are essential tools for ensuring drug safety and compliance in the U.S.

With 5 distinct types, DMFs play a pivotal role in supporting applications like NDAs and ANDAs.

Chris Reid and Thana Subramanian’s practical approach to drive innovation and quality.

While the CSA vs. CSV debate continues, adopting CSA becomes easier with critical thinking, real risk recognition, modern tools, value-driven records, and expert insights.

Navigating EU regulatory approvals for pharma and medical devices is complex, involving EMA, EC, and NCAs. Success requires choosing the right submission pathway, engaging early with regulators, and preparing compliant dossiers

The EU AI Act, effective August 2024, classifies AI-based medical devices as “high-risk,” requiring strict quality management, documentation, and risk oversight to ensure compliance and patient safety.