Securing a marketing authorization (MA) is just the beginning of a product's regulatory journey. Over time, adjustments or enhancements to the original authorization may be required to address evolving market demands, technological advancements, or regulatory updates. These variations can include process scale-ups, changes to product specifications, new dosage strengths, or the introduction of additional therapeutic indications.
Post-approval compliance also demands active monitoring to ensure adherence to conditions established during approval. At Medwisdom, we have supported clients in maintaining and evolving their products for decades, offering strategic insights and ensuring a seamless approach to regulatory changes.
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We help clients develop customized strategies for implementing necessary variations and maintaining regulatory compliance throughout the product lifecycle:
Customized strategies for modifications to manufacturing facilities or processes, adjustments to product characteristics, and shelf-life extensions to meet market requirements
Monitoring and tracking post-approval commitments, responding to regulatory queries promptly, and preparing detailed documentation to support ongoing compliance efforts
Organizing meetings with regulatory bodies, negotiating variation strategies and timelines, and ensuring clear communication to navigate post-approval complexities efficiently
Compiling and submitting comprehensive variation dossiers, and managing all documentation related to ongoing post-approval commitments for seamless regulatory processing
We provide end-to-end post-approval support to ensure your product remains compliant and competitive throughout its lifecycle:
Expert support for all types of post-approval variations including Type IA, IB, and II variations. We manage the complete variation process from strategy development and dossier preparation to submission and approval, ensuring minimal disruption to your product's market availability.
Systematic monitoring and management of all post-approval commitments including follow-up measures, risk minimization activities, and conditions attached to the marketing authorization, ensuring full compliance with all regulatory obligations throughout the product lifecycle.
Timely preparation and submission of marketing authorization renewal applications, including compilation of all required documentation and benefit-risk assessments to ensure uninterrupted market authorization and continued commercial availability of your product.
Prompt preparation of accurate and well-justified responses to queries raised by regulatory authorities during post-approval reviews or variation assessments, minimizing delays and maintaining productive relationships with authorities across all jurisdictions.
Management of all labelling changes required as part of post-approval variations, renewals, or regulatory authority requests — including updates to the Summary of Product Characteristics (SmPC), package leaflets, and packaging materials across all relevant markets.
Strategic long-term product lifecycle management to ensure your product remains competitive and compliant in an ever-changing regulatory landscape, including planning for line extensions, new indications, and market expansions with full regulatory support at every stage.
With a proven track record of supporting products across decades, we offer unparalleled expertise in managing the evolution of products and processes:
We have supported clients in maintaining and evolving their products for decades, bringing deep institutional knowledge of post-approval processes across multiple regulatory frameworks and product categories worldwide.
We provide strategic insights into product development and post-approval planning, ensuring our clients are well-positioned for future growth and compliance in an ever-changing regulatory landscape across domestic and international markets.
By choosing us, you gain a partner dedicated to simplifying the complexities of post-approval processes, allowing you to focus on delivering innovative and effective products to market while we manage your regulatory compliance obligations.
Find answers to common questions about post-approval services and our support.
Contact UsPost-approval changes to a marketing authorization are classified as variations and may require regulatory approval depending on their nature and impact. Common types include:
Medwisdom Lifescience provides expert guidance on variation classification and manages the complete regulatory approval process for all types of post-approval changes.
The processing timeline for a variation application depends on the type and classification of the variation and the regulatory authority involved. General timelines include:
Medwisdom Lifescience ensures variation applications are prepared accurately and submitted promptly to minimize review timelines and avoid unnecessary delays.
Managing post-approval changes involves a structured process to ensure regulatory compliance and minimal disruption to the product's market availability. The main steps include:
Yes, post-approval changes can potentially impact a product's market availability if not managed correctly. Key considerations include:
Medwisdom Lifescience helps clients plan and implement post-approval changes strategically to minimize any impact on market availability and ensure continuous regulatory compliance.
Regulatory authorities classify post-approval variations based on the potential risk and impact the change may have on the quality, safety, or efficacy of the product. Classification systems vary by region:
Medwisdom Lifescience has deep expertise in variation classification across all major regulatory frameworks, ensuring the correct pathway is selected for every post-approval change.
