Asphalion is an
international Scientific and Regulatory Affairs consultancy, with offices in
Barcelona and Munich.
We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices. Our involvement ranges from early development, through to registration and post-commercialization phases.
Since the company was founded in 2000, we have consistently grown and now have a team of over 80 employees with backgrounds in all areas of life sciences.
Our consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards.
We provide global services and work for hundreds of clients from around the world.
Through collaborations with partners in all other continents, we can accelerate your worldwide scientific and regulatory activities by using local expertise.
· Regulatory and Scientific Strategy during Development
· Medical and Scientific Writing
· Global Submissions
· eSubmission and RIM
· Life-Cycle Outsourcing
· Promoting the marketing registration of Medical Devices: Classification strategy, CE Marking and compilation of technical file.
|Sales markets||Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America|
|Primary business activity||Service|
|Affiliated categories:||Contract Services - Contract Services More|
CPhI Worldwide 20189 - 11 October 2018 Madrid, Spain We were at stand 3H70 See our Exhibitor Profile See full Exhibitor List
Our Top products
Asphalion S.L offers wide range of services which includes esubmission services. it has been at the forefront of electronic submission of regulatory data since the introduction of ectd. Experience is reflected in the countless valid ectd and nees submissions. It consist of preparation of ectd/nees for: europe...More info
Optimized Product Maintenance Services
Asphalion S.L offers wide range of services which includes optimized product maintenance services. It constitutes a large part of the workload of regulatory departments. Up to 70% of the activities during the life cycle of a medicinal product could involve maintenance. Product maintenance is thus a field with...More info
Regulatory Strategy Services
Asphalion S.L offers wide range of services which includes regulatory strategy services. Its strategic inputs from the very beginning: segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical plans with minimum time-to-market, and others. Contact us fo...More info
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