Once a medicinal product receives the Marketing Authorization approval and the product is ready to be commercialized, further regulatory requirements need to be taken into account throughout the product life-cycle to ensure a compliant, sustained, and successful product use.
Up to 70% of the post-approval activities of a medicinal product, including pharmacovigilance, could involve maintenance. Thus, product maintenance is a field with a large potential for improvement in both management and execution.
Asphalion has many years of experience in product Life-Cycle Management and is responsible for the portfolio maintenance of large, medium-sized and small pharmaceutical and biotech companies.
As a team of specialists in current medicinal regulations in EU, USA and many other countries, Asphalion can assist you in all medicinal product life-cycle management needs.
Life-Cycle Management Solutions
Regulatory strategy and maintenance support throughout product life-cycle post-approval:
Expert support on responses to Deficiency Letters.
Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) for eCTD publishing.
Ad hoc regulatory strategy.
Pharmacovigilance strategy and operations that responds to legal requirements and best enhances the safety profile of your product in real world application:
Management and follow-up of data and evidence generation post-approval.
Ensuring complete and constant subjection to compliance based on specific regional regulations:
Readability tests for further EU registration processes.
Data retrieval for price and reimbursement strategies.
Price and reimbursement for new medicinal products and for generic products in Spain.
Marketing Authorization transfer management.
Support in UK with new MHRA requirements:
Medical device related post-commercialization regulation:
Validation and qualification of medical devices manufacturing process, equipment and facilities.
SaMD validation for medical devices: Standalone software as medical device (SaMD). Computerized Systems as part of a medical device.
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Why Asphalion?
At Asphalion, we have many years of experience in product Life-Cycle Management and are responsible for product maintenance of large, medium-sized and small pharmaceutical and biotech companies. We provide this maintenance activities for multiple regional contexts, such as Spain, the EU and US in terms of maintaining and updating technical dossiers and CMC information, as well as reviewing promotional materials for compliant marketing.
Our company stays up-to-date in regards of the pharmacovigilance requirements and regulations. Also, considering the amount of information disseminated on social networks, we can help you monitor drug safety information that appears on social media sites with a new automatic Active Listening System.
Related Resources
A case study about Marketing Authorization Expansion in Europe. A small European
Pharmaceutical company with
local activity in its country, with a
growth strategy aiming to
expand to international
markets but lacking experience
and capability in managing
complex EU procedures.
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