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.
Promotional material compliance
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.
Complete support in Health Technology Assessment (HTA).
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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
The Electronic Application Form (eAF) is a unified EU form used for human and veterinary MAAs, variations, and renewals. It combines PDF for input and XML for data transfer, enabling data import/export, auto-copy, self-validation, and access to standardized term catalogues (EUTCT)—streamlining regulatory submissions and reducing manual input.
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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.
At Asphalion, we’re excited to be part of key events, conferences, and summits throughout 2026—great opportunities to connect, exchange insights, and collaborate with leaders across healthcare and medical devices.
DIA Europe 2026 will take place in Rotterdam from 24–26 March 2026. As Europe’s largest neutral conference in the life sciences sector, it will gather 1,500 professionals from over 50 countries for three days of exchange and collaboration. The programme features 10 dynamic tracks covering key areas such as Clinical Trials Innovation, AI & Real-World Evidence, Innovative Therapies, Medical Devices, and Pharmacovigilance, alongside 80+ sessions and contributions from 300+ experts, regulatory authorities, HTA bodies, payers, and patient organizations—offering a key platform to drive innovation and informed decision-making in healthcare.
Una representación de expertos de Asphalion, encabezada por nuestra CEO Núria Romero, asistió la semana pasada a la tradicional cena de Navidad de la Sección Catalana de AEFI en Barcelona.
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
