ASPHALION | ONE OF SPAIN´S TOP 10 COMPANIES BOOMING IN HEALTHCARE SECTOR 2022

We are over the moon to announce that Asphalion has been featured as one of Spain’s Top 10 Companies Booming in Healthcare Sector 2022 by Insights Care. As our Managing Director, Núria Romero says: “What makes Asphalion stand out is that we offer complete customer solutions: we are a one-stop-shop covering a full range of […]

📆 JUNE 14 | WORLD BLOOD DONOR DAY 2022

Today is World Blood Donor Day. Following this year’s campaign slogan, “Donating blood is an act of solidarity. Join the effort and save lives”, we would like to encourage everyone to join blood donors all over the world to donate. Giving blood is a life-saving act of solidarity and providing safe blood and blood products […]

HOUSE OF LORDS RECEPTION

Asphalion General Manager, Regulatory Affairs, Lidia Cánovas, together with Innovation Director, Oriol Penon attended on Friday an annual reception at the UK House of Lords in London. The event was hosted by Earl Attlee, a member of the House of Lords, and organised by the Clinical and Contract Research Associations (CCRA). The aim of the […]

ASPHALION REGTALK | The secret of Asphalion´s eCTD publishing success

We would like to get you acquainted with the Regulatory Information Management Systems (RIMS). The expert Udo Griem, Head of eBusiness Solutions at Körber Pharma Software and Lidia Cánovas, General Manager, Regulatory Affairs at ASPHALION will provide you with an overview about their expertise in RIMS.

STUDY DATA BY FDA

Are you planning to send a submission to the FDA? Will this submission contain study data? If the answer to these 2 questions has been yes, this brochure may be of your interest, since last year the FDA implemented the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER. Have a look at […]

FREE WEBINAR | Regulatory landscape in the UK: an update

📆 21st June, 2022     🕕3:00- 4:00 p.m. CEST With Brexit behind us and the UK establishing its own regulatory framework, companies face challenges about UK regulation. This webinar will provide you with insights into the medicines´ regulation in the UK, as well as a review of the regulatory requirements and procedures to gain or maintain […]

Orphan Drug Designation EU | Work process

The Orphan Drug Designation (ODD) is a status assigned by EMA to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market. We have summarized the work process […]

ASPHANET RA | ASPHALION´S NEW REGULATORY AFFAIRS SERVICE

At Asphalion we are introducing our new service, ASPHANET RA, a network of qualified partners that allows us to provide regulatory affairs services throughout Europe. Just to mention some of the local RA services that we can provide you with: National phases of DCPs and MRPs for initial MAA Management of national authorities´ portals Local […]

WORLD ENVIRONMENT DAY 2022 | ASPHALION´S SUSTAINABILITY GOALS

Climate change, nature and biodiversity loss, and pollution and waste are the evidence that, all around us, the earth is in “red code”. World Environment Day 2022 aims at accelerating a shift in this trend by implementing transformative changes in all our actions, transforming consumption, production, etc. At Asphalion health is at the center of […]