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.
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
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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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