Full Product Lifecycle Management for Successful Outcomes
A comprehensive scientific and regulatory strategy across all stages of the product lifecycle can help your team define a plan for long-term growth and success. After approval of your initial marketing authorization application (MAA), you need to remain compliant with all regulatory requirements (eg, post-authorization commitments, variations, renewals) to keep the product on the market. A strategic approach to lifecycle management is also valuable to maximize the potential of the product, potentially through line extensions or additional indications.
Acting as an extension of your team, ProPharma Group’s expert regulatory consultants bring a deep understanding of effective lifecycle management and have the knowledge to offer a complete regulatory solution for your product when marketed in the European Union (EU)/European Economic Area (EEA). We can partner with your team to provide:
- Regulatory advice
- Health authority liaison services
- Variation applications, line extensions, and renewals
- Support for post-authorization commitments
- Product information (PI) updates/translations
- Artwork reviews
- Management of catalog texts and local regulatory databases
- Readability testing
Line Extensions (LE) and Variations
Acquiring marketing authorization for a new medicinal product is an achievement in its own right but is often only the first of many benchmarks in the life of the product. Line extensions (LE) made possible through new indications, added formulations, and expanded drug delivery mechanisms are some of the ways an initial product can evolve to extend patent exclusivity and reach new markets, while helping to improve the health and safety of more patients.
Looking ahead at LE opportunities while maintaining consistency in the quality and manufacturing processes of an in-market product is a complex challenge faced by many marketing authorization holders (MAHs). Whether you are preparing for an LE or evaluating a potential variation to your product’s chemistry, manufacturing, and controls (CMC) process, ProPharma Group can help you successfully navigate the clinical, operational, and documentation aspects of the variation. We can work as an extension of your team or take care of the entire package, partnering with you to help maintain compliance throughout every change by:
- Developing a regulatory strategy for extending your product line or lifecycle
- Advising on regulatory requirements for variations and acting as project manager for the process
- Compiling, writing, preparing, and publishing the submission
- Serving as the primary point of contact with national and local health authorities
Throughout the product’s lifecycle, MAHs have an obligation to ensure the PI reflects current scientific data, the product safety information remains up to date, and the benefit-risk balance is still positive. Health authorities have strict legislative procedures for license renewal assessments and often require additional data or documentation, which may create challenges for your company. Having the appropriate resources to act quickly and efficiently is critical, as any misstep could have negative implications for your product’s license.
At ProPharma Group, our experts have a deep understanding of the science behind your product and are equally knowledgeable about the regulatory process and the expectations of the regulators. As an extension of your team, we can help you with every aspect of the license renewal process by:
- Managing timelines and documentation throughout the process, including submissions
- Preparing and submitting the renewal package
- Managing responses and communication with the European Medicines Agency (EMA) or local authorizing agencies as they arise
To ensure regulatory compliance, product information — including the summary of product characteristics, labeling, and package leaflet — must apply strict criteria and follow guidelines mandated by relevant filing procedures (ie, centralized, decentralized, national, or mutual recognition). Product information (PI) documents need to be accurate in multiple languages, requiring applicants to have a thorough understanding of local and national processes and the ability to translate documentation, standard statements, and terms to various European languages, including Icelandic and Norwegian.
At ProPharma Group, we understand the science behind your product and have a deep understanding of PI expectations from the EMA and national authorities. Throughout the application and post-authorization processes, our experts provide a wide range of PI services, including:
- Core Data Sheet including safety information and materials relating to indications, dosing, and pharmacology. Our experts help develop the Core Data Sheet, and make sure all regulatory requirements and timelines are met
- Local labels/harmonization text to harmonize national provisions so labeling is consistent throughout the EU marketplace. We understand the specific requirements of local health authorities and can assist with preparing and submitting all supporting documents
- Translations from English to various national languages within the EU. We help manage translations and assist in handling linguistic reviews to ensure accuracy for packaging, labeling, package leaflets, and artwork
- Implementation of PI changes to ensure all changes, including new adverse events or expanded indications, are up to date and compliant with all applicable regulations and requirements. We prepare and submit all supporting documents and can assist with ongoing maintenance and updates of PI changes based on EU and local regulatory requirements
Patient Information Leaflet (PIL) Testing
Patient Information Leaflet (PIL) readability testing is a legislative requirement for all medicines in Europe.
All medicines are required by European and UK law to be accompanied by a PIL setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately.
ProPharma Group offers a comprehensive PIL readability solution from new studies to bridging reports.