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:
Schedule a free meeting!
Discuss your case with our experts and receive a valuable feedback
Share
Why Asphalion?
Related Resources
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.
Highlights video
Highlights video
Highlights video
Highlights video
Highlights video
Highlights video
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.
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.
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).
Services
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
Memberships & PartnershipS
Quality Management System
Innovative SME
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
