Bridging EU and US: IND preparation and submission
IND preparation and submission business case: A small European biotech company focused on drug discovery and development interested in engaging with the FDA.
The European Union represents an important marketing opportunity in terms of dimensions thanks to the existing common regulations among countries via the centralized procedures. The pharmaceutical regulation in this region is governed by supranational bodies, such as the EMA and its working parties and associate partner authorities.
To succeed in the approach to these entities, a correct designation of the product and a detailed strategy about the best way to contact, timings, meeting preparations, obtention of proper advice, management of CTAs, among others, are crucial to achieve an accelerated approval.
The European Union represents an important marketing opportunity in terms of dimensions thanks to the existing common regulations among countries via the centralized procedures. The pharmaceutical regulation in this region is governed by supranational bodies, such as the EMA and its working parties and associate partner authorities.
To succeed in the approach to these entities, a correct designation of the product and a detailed strategy about the best way to contact, timings, meeting preparations, obtention of proper advice, management of CTAs, among others, are crucial to achieve an accelerated approval.
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Why Asphalion?
With 20+ years track record in handling submissions, Asphalion provides reliable support for all type of regulatory procedures in Europe. We provide regulatory strategy to anticipate any potential hurdle, coordinate your submissions and liaise with European agencies until the approval of the Marketing Authorisation.
Main benefits
Asphalion has large experience in writing, submitting and updating all types of technical dossiers specified for each product type including:
Furthermore, Asphalion has a proven track record and experience in following tracks, timings and standard formats in centralized submission procedures involving all intervenient regulatory entities.
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