EU, US, other selected regions.
Asphalion is an International Scientific and Regulatory Affairs Services consultancy with more than 15years of experience based in Barcelona with offices in Munich. We collaborate with Research Institutes, Pharma, Biotech and Medical Devices companies providing comprehensive regulatory assistance from the development status to the market approval/registration (EU, FDA and other selected markets, such as Israel) and also as local agents for vigilance and post-market activities. Our consultants are experts in their field and are in direct contact with Regulatory agencies for the development and implementation of new regulatory standards. We are also participating in some European projects H2020 as regulatory partners.
In addition, we provide in-house trainings, webinars, conferences and participate in events as lecturers on regulatory topics.
Areas of regulatory/reimbursement support:
Regulatory and scientific strategy during development – Drugs/Medical Devices/Biologics/ATMPs.
Roadmaps: non-clinical and clinical development plans, including assessment of feasibility, timelines and costs.
Scientific Advice: expertise for optimal outcome with EMA, EU-NCAs, FDA and other agencies.
Writing and Submissions: Medical Devices Technical Files, Registration Dossiers and Global Submissions for all products; Classification proposal and Optimal Notified Body search and proposal for Medical Devices.
Pharmacovigilance and post-market surveillance activities.