eCTD Publishing and eSubmissions
Seamless Regulatory Submissions Meeting Global Standards
Increased Efficiency
Streamline the submission process, reducing approval times and enhancing operational efficiency.
Guaranteed Compliance
Strict adherence to regulatory requirements for total peace of mind.
Expert Project Management
Advanced tools and project management expertise to meet critical submission deadlines.
eCTD Publishing and eSubmissions Service
Asphalion is at the forefront of streamlining electronic regulatory submissions through expert integration with the eCTD standard.
Our dedicated regulatory operations team, composed of seasoned specialists, delivers precision in eCTD publishing and eSubmissions. By fully embracing the eCTD format, we ensure seamless document submissions that comply with global regulatory authorities’ expectations.
Our service covers all aspects of eSubmissions, from the preparation, compilation, validation, and submission of electronic regulatory documents. Utilizing cutting-edge software and maintaining regular collaborations with industry experts and health authorities, every submission is meticulous and aligned with the latest regulatory expectations.
- Proven Experience:
Leading the implementation of eCTD with over a decade of managing more than 1500 eCTD sequences annually. - ISO 9001 Certification:
Ensuring traceability and secure storage. - Flexible Support:
Adaptability in a highly regulated environment allows for efficient and timely management of eSubmissions processes.
Meet our experts!
Vicente Tur
Regulatory Affairs Director at Asphalion
With extensive experience in the coordination and execution of EU Centralised Procedure submissions with the EMA and FDA submissions including IND, NDA, ANDA, BLA, art 505b, and DMF, Vicente is an expert in eSubmissions and eCTD. He has worked with multiple tools across various regions such as Health-Canada, GCC, and Swissmedic.
Additionally, Vicente coordinates the eSubmissions Working Group of AEFI (Spanish Association of Pharmaceutical Industry) and has conducted numerous trainings on Regulatory Affairs at the University of Barcelona, in client departments, and at the German Institute for Management.
Daniel Langa
Associate Director of Regulatory Affairs at Ashalion
European Medicines Agency SME
Daniel brings a strong academic background with a double degree in Pharmacy & Human Nutrition and Dietetics and a Master’s Degree in Research, Development, and Drug Innovation (R&D&I) from the University of Navarra.
With ten years of experience in pharmaceutical companies and regulatory consulting, Daniel has solid expertise in pharmaceutical industry operations and regulatory affairs.
“Asphalion leads in eCTD publishing globally, with expertise across diverse regulatory processes and dossier types.
Our team offers flexible solutions and high-quality publishing services worldwide for all pharmaceutical products.”
Discover how our eSubmissions solutions can transform your regulatory workflow
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
ASPHALION’s experts have delivered solutions to over 1,000 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 5,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
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