All Clinical Trials starting in the European Union have to comply with CTIS Regulation and be conveyed through the Clinical Trial Information System (CTIS) as the common portal, aimed at homogenizing and standardizing the process across the EU.
To facilitate CTIS uptake and CTR implementation to those needing support Assphalion is offering 3 different service packages:
Scientific and Regulatory Affairs Director
Christopher has a PhD in Biochemistry (Molecular biology) in gene therapy for muscular dystrophy.
He has been an academic researcher in gene therapy, muscle regeneration and muscular dystrophy as well as diabetes for 15 year and has published numerous original research papers and review articles in peer reviewed journals.
He is also an expert in medical and scientific writing for Advanced Therapy Medicinal Products (ATMPs), Biosimilars, Biological, Biotechnological and other Innovative products, and has also additional expertise in pediatric development (EU and FDA), Scientific Advice/ Pre-IND meetings and Centralized Procedures.
He has also been work package leader for several research consortia, including projects with ATMPs.
“We are proud to have been able to actively participate as a stakeholder in CTIS implementation.
We are in a position to offer detailed guidance to clients including different levels of training and advice.”
Tell us about your project, challenges or doubts. We will be happy to assist you!
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.
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!
If you are interested in our CTIS services, or wish to get in touch for a general enquiry, please contact us for more information.
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