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At Asphalion, we are proud to announce that Àngels Blasco has joined our team as Human Resources Director! Àngels brings extensive experience to this important leadership role. Her professional background, high capacity for people management and organization are an asset for our company. Her leadership is people oriented, aligned with the company strategy. The role […]

Have a look at this infographic that Extedo® and Asphalion have prepared with the summary updates in terms of publishing and eSubmission at a regional level. This month we are focusing on Australia! The Therapeutic Goods Administration (TGA) has started a staged transition to Electronic Common Technical Document[1]only (eCTD-only) for all regulatory submissions in Australia. […]

At Asphalion we are proud to announce that we are Regulatory partners of the consortium working on the RBDCOV_EU project 🦠💉🔬!! RBD Dimer recombinant protein vaccine against SARSCoV2 (RBDCOV) is a new Horizon Europe project led by the biotech pharmaceutical company HIPRA and funded by the Horizon Europe programme which aims at testing the efficacy, tolerability, […]

Since September 15, 2021, technical rejection criteria have been added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines regarding Study data standards. All the studies belonging to sections of Module 4 and Module 5 where datasets are mandatory, according to the standards specified in the FDA Data Standards Catalog, […]

Registration rollouts within Europe can be complex, especially in terms of choosing the right strategy for each country. Have a look at a recent success story of how Asphalion enabled a client to succeed with a multiple registration project in Europe. In this case, we jointly achieved over 40 MAs in 12 European markets, and […]

Version 5.0 of Harmonised Technical Guidance for eCTD Submissions in the EU has been released. This new version will come into effect on February 1st, 2022, substituting previous version 4.0, from April 2016. Main changes included in this new version are: More detailed indication on correction of content validation errors New indications for eCTD lifecycle […]

At Asphalion we are proud to announce that Talyta Carteano is now Associate Director!! Talyta started at Asphalion as Medical Device Manager and Lead Auditor in 2020, bringing over 10 years’ experience in the Medical Devices field. She combines a technical background with a fulfilling career in the fields of regulatory affairs, quality management systems, […]

Exactly a year ago, we launched #Asphawellbeing, a programme focused on the physical, psychological and emotional well-being of our employees, aimed at helping them minimize the impact that lockdown and home working had in everyone´s lifestyle. Now, after the experience gained during these past months, we have reshaped the programme in order to better adapt […]

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022.

From ASPHALION, we would like to inform you of the opening of the call: HORIZON-HLTH-2022-STAYHLTH-01-04-two-stage: “Trustworthy artificial intelligence (AI) tools to predict the risk of chronic non-communicable diseases and/or their progression” https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2022-stayhlth-01-04-two-stage It is widely recognized that health systems must put more emphasis on prevention and adopt a person-centered approach. Artificial intelligence (AI) along with […]

From ASPHALION, we would like to inform you of the opening of the call: HORIZON-HEALTH-2022-STAYHLTH-01-05-two-stage: “Prevention of obesity throughout the life course” https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2022-stayhlth-01-05-two-stage Obesity is one of the most serious public health challenges of the 21st century. Although health has improved in the EU over the last decades, the prevalence of obesity has tripled in […]

Many things have happened at Asphalion during these last 3 months: We are proud to have contributed to the fight against COVID-19 in 17 regulatory projects; we have launched two new services: CTIS and Support in SPOR/OMS for FDF and API manufacturers; we carried out two successful EUDAMED Webinars: “EUDAMED ISO IDMP” and “Module 2 […]

From ASPHALION, we would like to inform you of the opening of the call: HORIZON-HLTH-2022-DISEASE-06-03-two-stage: “Vaccines 2.0 – developing the next generation of vaccines” https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2022-disease-06-03-two-stage Infectious diseases, including antimicrobial resistant (AMR) infections, remain a major threat to health and health security in the EU and globally. The availability of more effective, accessible and affordable vaccines […]

From Asphalion we are proud to have collaborated once again in “La Marató”, a programme created in 1992 with the mission of fostering and promoting biomedical research of excellence, as well as raising social awareness. This year´s programme was dedicated to mental health: According to recent data for incidence and prevalence, the experts agree that one […]

As of end of July 2021, EMA requests MAHs of CAPs to submit their marketing status notifications via the IRIS Platform. As follow-up of the last EMA/Industry Platform meeting on the centralised procedure, an extension of the timelines in the implementation plan for IRIS Marketing status reporting from 6 to 9 months has been communicated. […]

From ASPHALION, we would like to inform you of the opening of the call: HORIZON-HLTH-2022-DISEASE-06-04-two-stage: “Development of new effective therapies for rare diseases”  https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2022-disease-06-04-two-stage This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. Despite the considerable amount of […]

At Asphalion we celebrated our annual convention again! Following all COVID-19 safety measures and protocols, we were able to meet again in person in “the new normal” after nearly two years without meeting face-to-face due to the pandemic. We were able to share experiences together through mindfulness and teambuilding activities, having lunch together, and carrying […]

From ASPHALION, we would like to inform you of the opening of the call: HORIZON-HLTH-2022-DISEASE-06-02-two-stage: “Pre-clinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs” https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-2022-disease-06-02-two-stage This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and […]

Have a look at this infographic that Extedo® and Asphalion have prepared with the summary updates in terms of publishing and eSubmission at a regional level. This month we are focusing on China! The final version of the specification v.1.0 was released at the end of September. Along with the release, it was announced that […]

Season´s greetings from Asphalion!!

For this reason, we decided to make a donation for each person that visited our virtual booths at the congresses we took part in 2021.

Due to our expertise and extensive knowledge in the regulatory field for innovative therapies and medical device development, Asphalion can provide with a sound value to Consortia planning to apply.

Last April, the first edition of ISO 20417:2021: Information to be supplied by the manufacturer – medical devices was published.

Today is Human Rights Day. Observed on December 10 since 1948, when the United Nations General Assembly adopted the Universal Declaration of Human Rights (UDHR).

Following this growth, we would like to announce that we have just moved to a new office in Madrid!

The objective of the event was giving an insight on key aspects of the entrepreneurship process within the healthcare sector.

At ASPHALION we can help you with outsourcing of “publishing” solutions every time of the year, but with only a month left to wrap 2021, many unforeseen events could happen.

Today is World AIDS Day, an opportunity to unite in the fight against HIV/AIDS, to show support for those who have been diagnosed and to remember those who have been lost to the disease.

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.

UnConference, an annual event by CataloniaBio & HealthTech organized as a debate of the future of therapeutic healthcare solutions, with the aim to raise awareness, perspectives and insight on the sector’s needs and opportunities, and how to tackle them.

WEBINAR | EUDAMED MODULE 2 Asphalion expert Fran Rodríguez unveils the new challenges EUDAMED Module 2 poses. To receive the link to the webinar, you can register here

The meeting, which was attended by all 11 partners with representatives from microfluidics, cell biology, cancer biology, physics, computer programming and regulatory affairs fields, was the first presential meeting of the Tumor-LN-oC consortium, allowing the participants to meet in person after six months of working together.