In the News

Kirsten Messmer and Charity-Anne Schuller discuss how to maximize regulatory intelligence and offer best practices recommendations.

John Watkins discusses investigational medicinal product dossier requirements for US sponsors planning to submit clinical trial applications in EU member states.

Steven Zdravkovic examines options for extractable and leachable studies to evaluate leaching from primary packaging into lyophilized drugs.

Niklas Morton explains how the new collaboration will help pharma companies create better optimized protocols that will prove to be more attractive to sites and investigators because they are tailored to their patient population.

The partnership will focus on data-driven feasibility, patient recruitment and real-world evidence offerings for both global and China-based pharma and biotech companies.

Peter Lynch discusses regulatory changes in Australia that are designed to lead to earlier access to lifesaving medicines for patients.

Kirsten Messmer outlines regulatory intelligence communication approaches for medium to large companies and highlights the advantages and disadvantages of each.

PPD expanding its biologics capabilities in Athlone to include cell and gene therapy analytical testing.

PPD Laboratories is focused on providing cutting-edge gene and cell therapy analytical testing services and capabilities around the world.