August 2023 Monthly Newsletter

Unlocking the Potential of Oligonucleotide Therapies: Overcoming Regulatory & Development Challenges. Discover how to navigate this cutting-edge field’s CMC, nonclinical, and clinical hurdles. Our experts at Zwiers Regulatory Consultancy, a ProductLife Group Company, are here to support your success!

Safeguarding Patient Safety: The Critical Role of QPPV in Pharmacovigilance Compliance. In the ever-changing world of pharmaceuticals, patient safety is paramount. Discover the vital role of the Qualified Person for Pharmacovigilance (QPPV) in upholding compliance and ensuring the effectiveness of medications. From monitoring Key Performance Indicators (KPIs) to identifying trends and patterns, driving regulatory compliance, and promoting continuous improvement, this article explores how QPPVs are crucial in preserving patient well-being.

Educational Materials for Medicinal Products: Empowering Safe Usage. A comprehensive guide on developing, approving, and monitoring accurate educational materials that inform healthcare professionals and patients while adhering to regulatory standards, ensuring safe and effective utilisation of medicinal products.

Overcoming RIM Implementation Challenges: Expert Strategies for Success! Learn methods to navigate data standardisation, system integration, compliance, and stakeholder communication hurdles in your RIM journey. Our RIMS team is here to support your seamless implementation!

Unlocking Excellence: Linguistic Reviews in Pharma Industry. Ensure quality & uniformity of PI across Europe. Challenges include language accuracy, time constraints, coordination with stakeholders, and template adherence. Partner with ProductLife Group (PLG) for expert solutions in linguistic reviews.

Accurate labelling is critical for compliance and patient safety in the pharmaceutical industry. Discover the hurdles in artwork creation and how ProductLife Group (PLG) offers expert solutions and enhance collaboration, validation, and resource access while reducing costs and accelerating time-to-market.

Developing Cell and Gene Therapies (CGT) or Advanced Therapy Medicinal Products (ATMP) faces hurdles: limited patient population for trials, complex Chemistry, Manufacturing, and Control (CMC), expensive development & reimbursement struggles, or safety & efficacy concerns. Guidelines exist but have gaps. EU’s Joint Clinical Assessments (JCAs) aim to expedite access but may encounter challenges. A specialised regulatory and compliance team is crucial for market sustainability. Together, let’s overcome obstacles and advance life-changing therapies for patients.

At PLG, we ensure the safety and efficacy of drugs throughout their lifecycle. Our expertise includes: identifying safety concerns during preclinical development, monitoring adverse events in clinical trials, collaborating with regulatory authorities for drug approval, conducting post-marketing surveillance for real-world safety data, implementing risk management strategies, performing Post-Authorization Safety Studies (PASS)

Unveiling the Role of Regulatory Affairs in Pharma Product Development: A crucial nexus between R&D, Clinical, and Regulations, these experts shape the product journey. From moulding Target Product Profiles to ensuring lifecycle compliance, they’re architects of success. Early engagement crafts strategy, mitigates risks and harmonises diverse inputs. Meticulous documentation bridges stakeholders and authorities while adapting to evolving norms. Beyond obtaining marketing authorisation, they ensure sustained adherence to standards. With multidisciplinary prowess, they unify Quality, Compliance, Clinical, and Manufacturing domains.

ProductLife Group is dedicated to recognising and reporting adverse events and product quality complaints for improved healthcare outcomes. At PLG, we offer expert case management services in pharmacovigilance, ensuring timely and accurate reporting to health authorities. Connect with us to discuss how we can contribute to a safer healthcare ecosystem.

Elevate client success with ProductLife Group. Our tailored teams blend personality and skills, ensuring a perfect fit for your needs. Key Performance Indicators drive our proactive approach, empowering us to anticipate and solve challenges. Led by visionary leaders, our teams deliver global solutions through a local lens. Let’s redefine success together! Understand the unique perspective of Fadime Kale, PLG’s Publishing Global Lead, on what she looks for in individuals when creating a team to meet the client’s needs.

Unlocking ASEAN Opportunities: Navigating CMC Perspectives in Medicinal Product Extensions! Check out our insights on extending US/EU dossiers to ASEAN countries, understanding regulatory differences, and ensuring successful drug approval

The landscape of in vitro diagnostic medical devices (IVDs) has undergone a seismic shift with the EU’s adoption of Regulation (EU) 2022/112. This amendment extends transition timelines for specific IVDs due to significant disparities between the IVD Regulation (IVDR) and the IVD Directive (IVDD). Stay informed with ProductLife Group to ensure seamless compliance transition and market continuity.