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Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich, Amsterdam and London.

Our services

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Regulatory and Scientific Strategy during Development

Minimizing time-to-market and maximizing cost efficiency by establishing the right strategy for the product development.

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Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.

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Global Submissions

Assessment of regional requirements based on experience and reliable coordination of local partners for global registration procedures.

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eCTD and RIM

Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.

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Life-Cycle Outsourcing

Maintenance work support to improve processes and maximize productivity.

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Pharmacovigilance

Case Management handling and implementing reporting tool. Providing support to set up a Quality system through PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices

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Latest news, tips, advice and fresh perspectives on Regulatory Affairs including: deadlines, updates, FDA, EMA, innovative solutions, Brexit, eSubmissions, drug development, guidelines, ODD, strategic consulting, scientific, procedures, roadmaps, etc.

Latest News

MISTRAL | EU-funded project to decipher the role of microbiome on HIV pathogenesis and cure

June 11, 2021
The EU-funded MISTRAL project is exploring the gut microbiota in relation to HIV-1, seeking microbiome biomarkers to support development of interventions that mitigate infection and enhance response to vaccines and therapies.

HONORING PRIDE MONTH

June 9, 2021
Pride Month commemorates the uprising at the Stonewall Inn back in June 1969. This sparked a liberation movement, a call to action to foster a culture where everyone feels comfortable being their full and authentic selves.

WEBINAR | Quality Management Systems: MDR and IVDR impact

June 4, 2021
Regulations EU/20174/745 (Medical Device Regulation- MDR) and EU/2017/746 (In Vitro regulation- IVDR) bring requirements for Quality Management Systems.

FORUM INSTITUT COURSE | Marketing authorisation procedures and lifecycle management

June 3, 2021
ASPHALION experts Lidia Cánovas, Vicente Tur and Ramón Hernández Moratinos, together with other four excellent speakers will share their in-depth knowledge with you and will provide you with practical tips on the requirements for new and existing approvals in Europe.