ProductLife Group expands expertise on Complex Products Development with the acquisition of Cilatus.

PLG is thrilled to announce its latest development – the acquisition of Cilatus BioPharma Consulting and Cilatus Manufacturing Services Ltd. This strategic move bolsters PLG’s capabilities to support drug development activities for clients worldwide.The combination of Cilatus and PLG product development teams will accelerate PLG’s goal of becoming the global reference partner in regulatory science to expedite development and access of HealthTech products to regulated markets, driving innovation and scientific progress.

EU affiliate landscape... A complex web

Navigating the EU regulatory landscape can be a complex web of requirements and nuances. Still, with over 25 years of experience, ProductLife Group’s global team of regulatory experts are here to guide pharmaceutical, biotech, and medical device companies to success.

Understanding the Nordic Market

Discover how the Nordic region is driving innovation in the life sciences industry and how ProductLife Group is adapting to meet the needs of its clients in this dynamic market.

From regulatory compliance to digital health solutions, PLG offers various services to support pharmaceutical and medtech companies in the Nordic region. With the acquisition of Pharma IT, PLG now provides expertise in data management and analysis, as well as regulatory intelligence and clinical trial management. With a focus on sustainability and social responsibility, PLG is committed to supporting its clients in meeting the demands of the Nordic market.

Market access: implications of the regional convergence trend on Biopharma and Medtech

The regional convergence trend in Market Access is transforming the landscape of pharma and MedTech in Europe. The implications are significant for manufacturers, from permanent EU frameworks for HTA to harmonization in digital health and the launch of coordination centers for real-world evidence. ProductLife Consulting highlights the challenges and opportunities of this trend, including the need for increased coordination, earlier market access planning, and country-specific expertise.

The Periodic Adverse Drug Experience Report in a nutshell

Understanding the Periodic Adverse Drug Experience Report (PADER) is crucial for pharmaceutical companies to ensure the safety and efficacy of their approved medicinal products. PADER is an aggregate safety report summarizing adverse events and reactions for a medicinal product within a specific reporting interval. It helps evaluate the medicine’s global safety experience and risk-benefit profile, ensuring the product label accurately reflects its potential risks and benefits. PLG is a one-stop solution that helps organizations prepare and submit PADER in the required format, ensuring compliance with USFDA regulations.

Responsibilities of the marketing authorization holder in relation to the qualified person responsible for pharmacovigilance (QPPV) in Europe

Ensuring the safety of medicinal products is crucial, and the Marketing Authorisation Holder (MAH) plays a significant role in appointing a Qualified Person Responsible for Pharmacovigilance (QPPV) in the EU. The QPPV monitors adverse drug reactions, conducts risk assessments, and provides information on safe product use. By ensuring that the QPPV has adequate resources, compliance, and access to relevant information, the MAH can ensure the safety and effectiveness of medicinal products.

Struggling to integrate third-party data into your system? ProductLife Group's expertise can help

Learn how we successfully migrated a smaller pharmaceutical company’s data into a leading pharmaceutical company’s VEEVA CRM system. Our experts conducted design reviews, risk analyses and provided project management, training, and bug-fixing procedures. Trust PLG to seamlessly integrate third-party data into your system.

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May 2023 Monthly Newsletter