DIA - Asphalion S.L. - Activity & Updates

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About

Regulatory

Compliance

Regulatory Compliance, Dossier & Application Development

Employees & Contact

151-300 Employee | 1 Contact

Year Founded

2000

Headquarters

151 Carrer de Tarragona, 10th Floor, Barcelona, Catalunya 08014, ESP

Activity

Showing 10 records

A L

1 month ago

added featured article

Decentralised Procedure Process Timetable

The decentralised procedure (DCP) is the European Union-wide procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State. The procedure falls under the Directive 2004/27/EC.

In the decentralised procedure, the applicant chooses one country as the reference Member State when making its application for marketing authorisation. The marketing authorisation in all chosen Member States is received simultaneously, enabling simultaneous marketing of the medicine and reducing the administrative and regulatory burden.

A L

1 month ago

added featured article

Asphalion Services

Access a comprehensive overview of our company through our Corporate Presentation. This document provides detailed insights into our mission, vision, and values, along with an overview of our core business areas, growth strategies, recent achievements, and future outlook.

Designed to offer a clear and concise perspective of who we are, what we do, and how we create value for our clients, partners, this presentation serves as an essential resource for understanding our organization.

Download it now to learn more about our value proposition, our team, and the opportunities we are driving.

A L

2 months ago

added featured article

FLYER | Transforming Regulatory Submissions in Singapore

Singapore has officially begun the transition to the electronic Common Technical Document (eCTD), a major step toward a more streamlined regulatory environment in the Asia-Pacific region. Key milestones include test submissions starting now, with full acceptance of eCTD dossiers from Q2 2026. The initial launch will cover new drug applications, generic drug applications, and drug master file applications.

Download our flyer to explore the key highlights and see how Asphalion can support your transition with expert eCTD services.

If you require any assistance, you can contact us at info@asphalion.com⁠⁠⁠⁠⁠⁠⁠

A L

2 months ago

added featured article

Poster | The new key player in Digital Transformation and Pharmacovigilance

Digital tools in pharmacovigilance are increasingly valued for their transformative potential. Integrating these tools requires a strategic approach merging technological capability with regulatory compliance.

A L

2 months ago

added a category to the listing

Asphalion S.L.

A L

2 months ago

followed

Asphalion S.L.

A L

4 months ago

added a social media link for

Asphalion S.L.

A L

5 months ago

edited the listing overview for

Asphalion S.L.

M B

7 months ago

edited the company sub heading for

Asphalion S.L.

V M

9 months ago

followed

Asphalion S.L.

Asphalion S.L.

Asphalion S.L.

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Decentralised Procedure Process Timetable

A L

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Poster | The new key player in Digital Transformation and Pharmacovigilance

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A L

Decentralised Procedure Process Timetable

A L

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A L

FLYER | Transforming Regulatory Submissions in Singapore

A L

Poster | The new key player in Digital Transformation and Pharmacovigilance

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