Description
Scientific and Regulatory Services ASPHALION is an International Drug Development and Regulatory Affairs Consultancy based in Barcelona.
Founded in 2000, ASPHALION has consistently grown for over 10 years and now consists of over 30 professional consultants with backgrounds in Pharmacy, Chemistry, Biology and Biotechnology.
ASPHALION is structured into working groups for International Registration Procedures, Clinical and Medical Writing, Electronic Submission of Regulatory Data, CMC/Quality and Pharmacovigilance.
ASPHALION offers comprehensive services, including:
- Assessment of Project Feasibility and International Regulatory Strategy
- Strategic Planning and Design of Non-Clinical and Clinical Development Plans
- Preparation and Submission of Regulatory Documentation (CTA, IND, IMPD, IB, MAA, NDA, eCTD, etc.)
- Contacts and negotiations with Regulatory Authorities worldwide
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facebook.com10.2.1.0
After 6 months of service withdrawal of EudraCT the new version 10.2.1.0 is now fully operational. EMA is now proposing a tight timeline of 6 months in which clinical trial results have to be entered into the system. This means that the results of all your studies finalized between 31 July 2015 and 31 December 2015 have to be entered by 31 July 2016. In addition, for studies to be posted < 24 months after completion the deadline is extended till the end of 2016. With this new version, EMA drives one step further to the achievement of Transparency in Clinical Trials in Europe, whose summary results will be made publicly available through the EU Clinical Trials Register (EU CTR). Asphalion can support you with the update of your studies into EudraCT. Should you request additional information, please do not hesitate to contact us at info@asphalion.com
Timeline Photos
#Asphanow #onair Remco Munnik, our Regulatory Information Director, participating in a panel discussion talking about the “Challenges of the current variations system” and possibilities to improve the current system in future. #Asphalion #EGAreg16
Timeline Photos
Tomorrow, Remco Munnik, our Regulatory Information Director, will be presenting at the 15th EGA Regulatory and Scientific Affairs Conference in London. The first day Remco will be part of a panel discussion to talk about the “Challenges of the current variations system”. The second day Remco is chairing a session on “EU telematics environment- what’s new?”, with a presentation about the “Road map on eSubmission” and part of a panel discussion concerning “Brief look to the future - Interoperability of systems and various projects - how to connect dots and to create synergy”.
Open Seminar - Registration
Don't miss it! We are excited to invite you to our Open Seminar 2016 - FDA Road to Success, in the city of our branch office in Munich, Germany. On 9 and 10 of March, we will together with Extedo and our US Agent, Bruce Thompson, present the latest FDA developments and general requirements.We will be sharing our experience with FDA submissions and emphasize on how to solve common obstacles and critical issues. Looking forward to meeting you there! For more information and registration click here: http://www.asphalion.com/openseminar/
Asphalion's cover photo
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We are excited to announce a new edition of our FDA OPEN SEMINAR, which will take place on 9-10th March'16 in Munich (Germany). This time, the seminar will be further improved: Asphalion has teamed up with its partner EXTEDO to offer a practical eCTD workshop, focused on FDA submissions. For more information and preliminary agenda: bit.ly/1kRH1Wp Please feel free to forward this information to your contacts that might be interested in this topic.
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