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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Asphalion End to End support during product lifecycle
Elevating Safety Standards Across Medicinal Products and Medical Devices
Asphalion contributions to the fight against COVID-19
(CTR) No 536/2014
We are providing specific training for pharma and biotech companies inorder to guide them through the correct implementation of the new system.
Meet the ASPHALION team at the Advanced Therapies congress! Join our experts Christopher Mann and Oriol Penon in London, who will be available at booth 95 to present you Asphalion and
DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.
The updated Environmental Risk Assessment (ERA) Guidelines, effective from September 2024, introduce stricter regulatory requirements for medicinal products. These changes demand a thorough environmental evaluation for all new Marketing Authorization
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