Safety writing through product lifecycle
Elevating Safety Standards Across Medicinal Products and Medical Devices
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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Why Asphalion?
Related Resources
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.
Preparing and submitting an Investigational Medicinal Product Dossier (IMPD) is a crucial step in the drug development process. At Asphalion, we offer reliable and comprehensive IMPD writing services to ensure
Celebrating a Milestone in Medical Nanotechnology!
For companies engaged in clinical development programs for pharmaceutical products, robust regulatory support is essential for obtaining trial approval and initiation, as well as maintaining regulatory compliance throughout the process.
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