ASPHALION´S HIGHLIGHTS | Second quarter 2024
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After the UK’s withdrawal from the European Union took place, the UK regulatory context separated from that of the European Union, what posed a challenge for pharmaceutical companies in order to understand to what extent their market activity would be affected.
This change led to the need of providing support both for adapting past casuistries to the new regulatory environment and to generate strategic projects for new commercialization, such as in:
Altogether, these services are provided based on the following aspects:
UK Regulatory Affairs Services Solutions
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Why Asphalion?
Asphalion is fully prepared and experienced in acting as a local UK support to successfully manage your relationship with government and medical entities (MAH, MHRA, among others). As such, our experts are aware of the post-Brexit new regulatory requirements.
In fact, Asphalion counts with an office in the United Kingdom to help manage potential key contacts with regulatory entities to facilitate any administrative issue related to clinical development, registration, commercialization and adequate product maintenance.
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This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.
As a company, at Asphalion, we constantly endeavor to lead in embracing the latest trends. In this spirit, we wholeheartedly dedicate ourselves to integrating digital tools that streamline our processes, enhance our efficiency, and enable us to deliver unparalleled quality to all our clients.
At Asphalion, we are thrilled to announce the opening of our new office in Pamplona! This strategic decision reflects our commitment to being closer to our clients and strengthening our
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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