Asphalion | AseBio - Asociación Empresas Biotecnología

Asphalion is an International Regulatory, Scientific & Safety Consuting in Life Sciences with offices in Barcelona, Madrid, Pamplona, Munich and London. Asphalion provides Expert consulting, strategic advice, operational support and full outsourcing services for all product life cycle stages.

We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.

Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards, delivering solutions for Pharmaceutical, Biotechnological and Medical Technology companies, covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and Data Management for both Medicinal Products and Medical Devices.

ASPHALION offers strategic advice, expert consulting, operational support, as well as full outsourcing services for all types of products in all therapeutic areas.

To deliver the best possible solution in each project, ASPHALION works closely with international competent authorities, notified bodies, scientific associations and key opinion leaders and maintains a comprehensive network of geographic and functional partners.

Productos y servicios

Our services include:

Regulatory and Scientific Strategy during Development.
Medical and Scientific Writing.
Global Submissions.
Regulatory Operations: eCTD, eSubmissions and Nees.
Regulatory Operations Data Management.
Life-Cycle Management.
CMC Solutions.
Safety.
ATMPs and Biologics.
Medical Devices.
Drug Development Project Start-Up & Planning.
Pharmaceutical Business Development.

Why Choose Asphalion

Accelerate Your Sucess: Speed up processes, save time and resources with fast, independent expert opinions.
Enhance Project Value: Add strategic insight and operational efficiency to every stage of your product lifecycle.
Validate Your Strategy: Ensure your development and regulatory plans align with international standards.
Work With a Global Team: Tap into our international team of experts for seamless collaboration.
Enjoy Continuity and Support: Rely on dedicated working teams and consistent contact points for your projects.
Maximize Flexibility: Adpat to ever-changing regulatory demands with our tailored, ad-hoc support.
Simplify Compliance: Optimize workflows and minimize efforts.
Navigate Complex Challenges: Achieve success even with intricate regulatory procedures and requirements.
Experience Excellence: Discover a professional, reliable, and solution-driven partner who puts your success first.

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