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
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.
Meet Our Experts at BIO Europe Spring!
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!
