Post-Approval Maintenance
Navigating the complexities of post-launch regulatory compliance is essential for biopharmaceutical companies. Our comprehensive Post-Launch Outsourcing regulatory services support biopharma companies worldwide with end-to-end lifecycle management and market expansion of established product portfolios to maintain and improve revenue streams while helping to control costs.
Contact our specialists to tailor a service plan
After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use. However, maintenance obligations must continue to be met in all regulated areas.
To retain Marketing Authorization, the MA holder must continually:
- Update work to ensure the approved dossier is valid
- Address safety surveillance issues by having pharmacovigilance systems in place
- Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
- Respond to renewal requirements, as necessary
Challenges that accompany large product portfolios, differing global markets, evolving regulatory landscapes, and stakeholder expectations can further increase the complexity, unpredictability and intensity of the Post-approval Phase.
Changes in development and regulations require continuous updates to systems, documents and agreements. Consequently, time and resources may be strained, causing new product development to suffer.
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Our Regulatory Post-Launch Outsourcing (PLO) services provide a trusted solution for cost-effective maintenance of established product portfolios. We help companies of all sizes around the world manage increasing regulatory complexity to:
- Reduce Operational Costs: By leveraging external expertise, companies can cut down on maintaining internal regulatory teams.
- Enhance Agility: Access to specialized skills enables organizations to quickly adapt to regulatory changes.
Focus on Innovation: Freeing internal teams from routine tasks allows them to concentrate on strategic growth and innovation.
Our holistic approach integrates regulatory expertise with operational excellence, enabling streamlined processes to help comply with shifting global, regional, and local regulatory requirements.
- Global to Local Integration: We harmonize regulatory management across various markets.
- Risk Mitigation: Our model helps minimize regulatory risks and meet the requirements of evolving regulations.
- Operational Efficiency: By optimizing maintenance operations, we enhance overall productivity and reduce costs.
With a diverse team of over 360 regulatory submission experts, PharmaLex is uniquely positioned to support your regulatory needs.
- Experienced Professionals: Our experts bring decades of experience working with global health authorities.
- Deep Regulatory Knowledge: We understand the intricacies of the regulatory landscape, delivering high-quality support.
- Comprehensive Guidance: From strategy to execution, we provide end-to-end regulatory services.
Whether you’re a multinational corporation or a mid-sized biopharma company, our services are tailored to meet your needs:
- Flexible Engagement Models: From full portfolio management to targeted support for individual products.
- Customized Services: Solutions designed to align with specific regulatory requirements.
- Scalable Solutions: Our services grow with your organization, helping achieve continuous support as your needs evolve.
PharmaLex has collaborated with a Top 20 biopharmaceutical company for over a decade, focusing on optimizing regulatory processes while significantly reducing costs. The client sought to free its regulatory affairs professionals from routine tasks to concentrate on innovation and new brand launches.
Challenges
- Need to maintain maximum market availability for core products.
- Desire to reduce operational costs and overheads while meeting regulatory requirements.
- Requirement for a strategic outsourcing partner to support evolving regulatory needs.
Solution
- Implemented a tailored Post-Launch Outsourcing program starting in 2014, initially for a few established products.
- Deployed 20 PharmaLex staff at the client’s global headquarters in Europe.
- Expanded services to include CMC, publishing, and submissions for over 80 products globally.
Results
- Achieved a 20% overall reduction in workload within 2-3 years.
- Enabled the client to focus on strategic initiatives, enhancing market availability and driving future growth.
Available Resources
FURTHER RESOURCES
Infographics
With over 33 offices around the globe, our highly specialized network customizes optimal, region-specific solutions for the Post-approval Phase.
Emerging Smart technologies employ computerized and automated service lines, including our PharmaLex Partnerships database, to free up time and resources—so you can focus on what is important.
Discover technology that helps you:
- Orchestrate all global activities for GxP management within a single cloud solution
- Automate case processing and safety literature
- Audit incoming case safety reports
- Manage pharmacovigilant agreements
- Transition to a fast, holistic solution for paperless compliance
- Evaluate possibilities with the Risk Assessment Tool for Excipients (RATE)
- Analyze GxP vendor metrics
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