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.
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.
During these two interactive days, actors of the healthcare community alongside world experts in biosimilar medicines will gather and debate the evolving biosimilar medicines landscape and emerging trends. Discussion will focus on sharing good practices and setting collective aims to achieve the depth, breadth and speed of the use of biosimilar medicines as a lever to untap their transformative value.
Harness the power of convenience with Asphalion’s scheduling tool – a streamlined way to arrange a meeting with our Regulatory and Safety experts.
Watch Asphalion experts Carlos Domingo Palacios, Beatriz Ugalde, Adi Ickowicz, Rosa Sellabona, Álvaro Villarino, Vanesa Palau González, PhD and Daniel Langa García navigate the most critical topics influencing the Regulatory
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