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Product Development
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Clinical Trials
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Quality
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GxP Audits
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Regulatory Affairs
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Pre-authorisation
- Regulatory Roadmap
- Scientific Advice
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Product information
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Dossier preparation
- Dossier Gap Analysis
- MA Handling
- Post-authorisation
- Regulatory outsourcing
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Pre-authorisation
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Pharmacovigilance
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QP Service / Importer
Product lifecycle management
Obtaining a Marketing Authorisation (MA) is a significant milestone, but it’s not the end of the journey. Effective product lifecycle management is crucial for maximizing your product’s potential. At SciencePharma, we understand that it’s just the beginning. Maintaining your MA and maximizing your product’s potential requires ongoing effort and expertise. Navigating the complex landscape of regulatory requirements, post-authorisation activities, and lifecycle management can be challenging. That’s where we come in.
There are many duties and responsibilities placed upon the Marketing Authorisation Holder regarding maintenance of MA, e.g. timely payment of annual fees, updating the dossier in line with technological progress, application for safety variations and others. Moreover, as time passes, some post-authorisation activities should be carried out, although they are not obligatory, they increase the attractiveness of the product. SciencePharma provides comprehensive product lifecycle management services, ensuring your MA and dossier remain up-to-date, compliant, and optimized for market success. We handle the intricate details, allowing you to focus on what you do best: bringing innovative products to patients.
Our product lifecycle management services include:
- All types of variations management (type IA and IAin, type IB, type II variations and notifications) – Our deep understanding of regulatory guidelines ensures seamless and efficient processing of your applications. We minimize delays and keep your product information current.
- Line extensions applications – We can assist with line extension applications, navigating the regulatory complexities and ensuring a smooth transition for your new offerings.
- Sunset clause exemptions applications – We can help you secure exemptions, ensuring continued market presence.
- Annual fees – We manage these payments on your behalf, preventing any lapses in your MA.
- Renewals – Our team will handle the entire renewal process, ensuring timely submission and minimizing any potential disruptions.
- Withdrawals – If withdrawal becomes necessary, we can manage the process efficiently and compliantly.
Contact us today to discuss your product lifecycle management needs and discover how SciencePharma can help you achieve your goals.