Other countries

Assessing the regulatory context of ROW countries together with local partners to ensure the smoothest marketing

Other countries

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.

Other countries Solutions

  • Strategic Regulatory roadmap adapted to each country context and depending on the type of product to be approved:
    • Evaluation of regional regulatory requirements
    • Assessment of main regulatory bodies involved through your product registration and commercialization
    • Assessment of the timings and procedures, as well as of documents to be submitted


  • Support and management in market authorization counterparts specific to each country


  • Global roll-out in emerging markets


  • Reliable coordination of local partners for global registration procedures

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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

Access consortium

Access Consortium

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.

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