health authority review

Life Cycle Management

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’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

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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).

License Renewal

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.

Product Information

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, 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:

• 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

Health Authority Interaction

Regulatory Strategy

As the global leader in regulatory consulting, ProPharma is able to develop a complete strategy that will give you confidence in the forecast of key milestones, necessary documentation, overall effort, cost, and plan of action. A sound strategy is a crucial component to success, as it provides input into all drug development efforts.

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Global Quality & Compliance

ProPharma specializes in solving complex challenges.  Our experienced consulting professionals will seamlessly integrate with your team to do more than simply identify potential risks. We provide recommendations to mitigate those risks and will work side-by-side with you to implement improvement plans and collaborate with your team in addressing those risks.

ProPharma performs quality and compliance consulting activities in all GxP areas.  Our consultants have extensive management and operational experience in at least one GxP area (GMP, GDP, GVP, GCP, GLP, GCLP, and/or IT/CSV) and often in multiple areas of expertise.

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