Clinical Trials (CTs)
Transition to Clinical Trials Regulation EU 536/2014 and CTIS
Asphalion’s Medical and Scientific Writing team provides you with support to build the foundations of strong non-clinical and clinical developments.
Our team has 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.
Medical and Scientific Writing Solutions
We provide specialized expertise in key areas, ensuring a smooth and efficient path to product approval and commercial success:
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Transition to Clinical Trials Regulation EU 536/2014 and CTIS
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(CTR) No 536/2014
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