Medical Devices Scientific and Regulatory Services
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
Despite a decrease of innovative new chemical entities in the pipelines of pharmaceutical companies, we continue to work in numerous origination projects that promise to bring important treatment improvements for patients around the world.
On the other hand, many small molecules are well-known drugs with many years in the market, but they are still a major market and hold several potential opportunities, for example, drug repositioning. Many activities should be performed in a robust and efficient way, such as life cycle maintenance, registration in new markets or pharmacovigilance.
Despite a decrease of innovative new chemical entities in the pipelines of pharmaceutical companies, we continue to work in numerous origination projects that promise to bring important treatment improvements for patients around the world.
On the other hand, many small molecules are well-known drugs with many years in the market, but they are still a major market and hold several potential opportunities, for example, drug repositioning. Many activities should be performed in a robust and efficient way, such as life cycle maintenance, registration in new markets or pharmacovigilance.
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Why Asphalion?
Asphalion’s team has extensive experience in the pharmaceutical industry and broad scientific and technical background in the areas of non-clinical, clinical and CMC. Asphalion has also experience in providing regulatory support during development and registration of chemical drugs, including generics, new chemical entities and fixed dose combinations (FCD), among others.
Related Resources
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
All what you need to know about the impact of MDR on Directive 2001/83/EC.
A lot of things have happened at Asphalion during these past three months, and we have summarized the highlights in a two minutes video. You can watch it HERE: Hope
Have a look at the slides to see how Asphalion´s expertise can help you with your regulatory processes. Our dedicated subject matter experts can provide you with successful, high-quality support
A lot of things have happened during these past three months. We received an award from AEFI as most engaged Company with its employees’ traning; we gave our MedTech services
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