Asphalion’s teams have both academic research experience and a broad regulatory and technical background in the development and registration of Biologics, including all types of Advanced Therapy Medicinal Products (ATMPs). Our expertise allows us to select the best possible regulatory strategy for your Biological product.
Asphalion can elaborate all regulatory, non-clinical, clinical and CMC documentation required during development, registration and life cycle of Biologics. In addition to this, strategic inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimum time-to-market, among others.
Biologicals Solutions
Ad hoc regulatory advice and strategic consultancy:
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Why Asphalion?
Thanks to our extensive experience working with Biological products and Biosimilars, we are the ideal partner for defining the best regulatory strategy for our clients´ Biological products.
As part of our modular and flexible support model, we can either assist you with gap analyses of existing documentation or take on the preparation of entire registration dossiers.
We can advise on critical interactions with authorities, such as scientific advice procedures, and can manage them completely for our clients.
Difficult topics, like the extrapolation of indications, are assessed and managed by our senior experts.
We have successfully written full biosimilar dossiers, including all CMC parts, non-clinical and clinical sections, have prepared and attended pre-submission meetings with EMA, and have supported the management of Centralised Procedures and Biologics License Applications, including elaboration of responses to authorities.
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Asphalion contributions to the fight against COVID-19
Scientific & Regulatory Affairs Support during development of ATMPs & Biologics
We are pleased to announce that ASPHALION will participate in the third edition of Connection Day, organised by Catalonia.Health, which will take place on April 29th at the World Trade
DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.
ASPHALION es una empresa internacional líder en Consultoría Regulatoria, Científica y de Seguridad en Ciencias de la Vida. Apoyamos a las empresas en el desarrollo y autorización de medicamentos, desde
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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