ProductLife Group announces the reinforcement of our scientific expertise with the integration of RNI, a consulting firm providing global regulatory and scientific services across the entire spectrum of Nutrition and Consumer Healthcare products

ProductLife Group expands expertise in OTC Products Development with acquisition of RNI. PLG is thrilled to announce the acquisition of Rni, a consulting firm providing global regulatory and scientific services across the entire spectrum of Nutrition and Consumer Healthcare products. The RNI team will further enhance PLG’s ability to capture the growing customer demand for services to market safe and healthy products, globally.
Read the full press release

Understand the way paved by European Commission's HTA Regulation for streamlined assessments and improved market access to innovative medicines

Discover the power of promotional videos in change management for eDMS implementation projects. Learn how effective communication, addressing human challenges, and leveraging video content can drive the successful adoption of regulatory document management systems. Enhance engagement, educate stakeholders, and ensure compliance with PLG’s expertise in end-to-end video production.
Read more about the HTA Regulation

Ensuring Safety and Compliance: the Crucial Role of Labelling Updates

Labelling Compliance Made Easy: Partner with ProductLife Group (PLG) for comprehensive support in navigating regulatory requirements, multilingual translations, and tight timelines. Our reliable labelling services ensure accuracy, compliance, and efficient artwork management
Learn about the role of Labelling Updates

Revised FDA Guidance on Generic Transdermal and Topical Delivery Systems

Stay Informed with the Revised FDA Guidance: Gain valuable insights into the design and conduct of studies for generic transdermal and topical delivery systems (TDS). Learn about updated recommendations for assessing adhesion and measuring irritation and sensitisation potential. Discover alternative scales, statistical analysis methods, and instances where in vivo studies may be waived. Stay ahead in TDS development with the latest guidance
Find out about the latest changes in the FDA Guidance

Driving Quality Compliance Improvement: Leveraging Operational Excellence and Change Management for a Sustainable Performance

Do you wish to see PLG experts explaining how operational quality can become a source of performance and savings for your business?! Ismaël Riazul, Diana Vartanyan, and Malik Metahri presented on June 15th how to achieve cost-effectiveness and reduce risk thanks to optimised processes. Benefit from their 50 years of cumulated experience in “Sustainable Performance Improvement”, “Increased Productivity”, and “Process Optimisation”.
Watch the first seven minutes of the conference

Q9(R1) Quality Risk Management

Harness the power of effective risk management to ensure drug safety and compliance.

Discover the latest guidance from USFDA on Q9(R1) Quality Risk Management and how it can enhance your pharmaceutical quality processes. Learn about the principles, tools, and methodologies involved, enabling better risk-based decisions for drug substances and medicinal products.

Read about the latest guideline here

Introducing Artificial Intelligence and Machine Learning in the Pharmaceutical Industry

Revolutionizing Drug Development: USFDA’s Journey into AI and ML. Explore the transformative power of artificial intelligence and machine learning in the pharmaceutical industry.

Join the conversation on future innovations and shaping the future of healthcare.
Understand the latest AI/ML trends

Introduction to the Asean Common Technical Dossier (ACTD) for Pharmaceutical Registration

Unlock Your Market Potential with ACTD: Streamline your pharmaceutical registrations in ASEAN countries with our expertise.
Our team at Product Life Group (PLG) can assist in converting and publishing your dossiers in the ASEAN Common Technical Dossier (ACTD) format.

Find all you need for your next Asean Submission

Simplified Global Drug Approvals: Introducing the Access Consortium

Transforming Global Drug Approvals: Unleashing Collaboration through the Access Consortium’s Work-Sharing Initiative. Learn how this streamlined approach is accelerating access to life-saving treatments by reducing duplication of effort and allowing pharmaceutical companies to submit a single application to multiple health authorities.
Read more about the Access Consortium

Simplified Global Drug Approvals: Introducing the Access Consortium

Transforming Global Drug Approvals: Unleashing Collaboration through the Access Consortium’s Work-Sharing Initiative. Learn how this streamlined approach is accelerating access to life-saving treatments by reducing duplication of effort and allowing pharmaceutical companies to submit a single application to multiple health authorities.
Read more about the Access Consortium

Comparison between WHO-UMC Causality Assessment and Naranjo ADR Probability Scale

Comparing WHO-UMC and Naranjo ADR Scale: Evaluating Drug-Related Adverse Events with Precision and Simplicity. Discover the two main methods for assessing the causality of medication-related adverse events: the WHO-UMC (World Health Organization-Uppsala Monitoring Centre) method and the Naranjo Adverse Drug Reaction (ADR) probability scale. This in-depth analysis examines the strengths and limitations of each approach.
Discover the differences between the two methods

New Protocol Amendment for Ireland - Northern Ireland: A Windsor Framework

Learn how the protocol aims to resolve border issues post-Brexit and the impact on medicines, regulatory challenges, and market consequences. Stay informed about the evolving EU-UK relationship and its implications for the pharmaceutical industry.
More details on the Windsor Framework

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July 2023 Monthly Newsletter