Global portfolio Due Diligence
Business Case: A big EU pharmaceutical company, interested in acquiring a whole set of worldwide brands from a company.
The contextualization of product strategies into local regulatory environments depends on the specific juncture of each country, which can be highly diverse and changing. Landing such strategies to local requirements is as necessary as it is challenging, precisely due to the degree of differences in the real world. Therefore, concrete mapping of intervenient laws, regulatory entities and timings become fundamental for successfully commercializing a therapeutic product.
To this purpose, Asphalion has both the knowledge of how to face new and complex regulatory frameworks, as well as partners all over the world that can assist in hitting the spot in rest of the world countries that have been strategically identified for your company’s purposes.
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Why Asphalion?
Asphalion counts with a network of partners to transfer the knowledge and experience within the EU to the specific context in each region. We have extensive experience in LATAM countries and increasing coverage of ROW countries.
Related Resources
Business Case: A big EU pharmaceutical company, interested in acquiring a whole set of worldwide brands from a company.
The Access consortium is a medium-sized coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the UK that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
Asphalion contributions to the fight against COVID-19
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Meet the world of pharma in one place
On 18th June 2024, a new version 3.1 of the EU eCTD M1 specification was published on the eSubmission website, marking a significant milestone in the electronic submission of medicinal
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