Asphalion’s Regulatory and Strategic Consulting team offers comprehensive support throughout the drug development process, from initial stages to market launch.
Our team has academic research experience and a broad scientific background in non-clinical, clinical and CMC writing for different types of products, including innovative, biological, biotechnological and advanced therapies medicinal products. Asphalion’s expertise allows us to offer the best regulatory strategy for each project.
We can support you with all sort of regulatory related documentation required during the clinical development and registration. In addition to this, strategic inputs can be provided from the very beginning for segmentation/niche indication, conditional approval/fast track, orphan drug designations, preclinical and clinical development plans with minimal time-to-market, among others.
Drug Development Consulting Solutions
We provide expert guidance and solutions in all the required areas, ensuring a seamless journey towards successful product registration:
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The Electronic Application Form (eAF) is a unified EU form used for human and veterinary MAAs, variations, and renewals. It combines PDF for input and XML for data transfer, enabling data import/export, auto-copy, self-validation, and access to standardized term catalogues (EUTCT)—streamlining regulatory submissions and reducing manual input.
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Embrace the Power of Smart Regulatory Strategy during this week! At Asphalion, we are dedicating this week to delving into the field of Life-Cycle Management, starting today with this infographic about the electronic application form (eAF).
At ASPHALION we are pleased to announce our participation in RAPS EuroConvergence 2025, one of the premier regulatory affairs events in Europe. This year’s conference will be held at the
ASPHALION es una empresa internacional líder en Consultoría Regulatoria, Científica y de Seguridad en Ciencias de la Vida. Apoyamos a las empresas en el desarrollo y autorización de medicamentos, desde
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