Prior to entering clinical trials to confirm in humans the results obtained in preclinical research, a product needs to be correctly defined to ensure the best regulatory strategy and clinical approach. Facilitating a correct definition of the research development and regulatory plan, which involves proper designation of the product, will determine: timings, requirements during later phases, types of meetings to be carried out, the regulatory intermediaries that will be involved, and the possibility of accessing waivers and other mechanisms to accelerate approval that will depend on the medical need to be covered and the nature of the product.
Strategic regulatory inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast-track, orphan drug designations, and preclinical plans oriented for minimum time to market.
Asphalion can be the ideal regulatory partner during these early stages prior to proceeding to clinical research or in the very early stages of clinical research.
Prior to entering clinical trials to confirm in humans the results obtained in preclinical research, a product needs to be correctly defined to ensure the best regulatory strategy and clinical approach. Facilitating a correct definition of the research development and regulatory plan, which involves proper designation of the product, will determine: timings, requirements during later phases, types of meetings to be carried out, the regulatory intermediaries that will be involved, and the possibility of accessing waivers and other mechanisms to accelerate approval that will depend on the medical need to be covered and the nature of the product.
Strategic regulatory inputs can be given from the very beginning for segmentation/niche indication, conditional approval/fast-track, orphan drug designations, and preclinical plans oriented for minimum time to market.
Asphalion can be the ideal regulatory partner during these early stages prior to proceeding to clinical research or in the very early stages of clinical research.
Preclinical development stage Solutions
Early phase regulatory meetings:
Scientific Advice meetings:
Regulatory Tools
Orphan Drugs Designation (ODD)
Paediatric Investigational Plan (PIP)
Support in Clinical Trial Application in EU (preparation and submission), UK and US.
Advanced Therapy Medicinal Products (ATMP) Specific Services:
Call management, presentation and project execution.
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Why Asphalion?
Asphalion’s team has an extensive academic research experience and broad scientific background in the area of non-clinical and CMC writing for Innovative, Biological, Biotechnological, and Advanced Therapy Medicinal Products. The experience of Asphalion’s team allows the selection of the best regulatory strategy for early developments.
Asphalion has been supporting early development projects for more than 20 years, providing regulatory advice and regulatory strategy for the development and further commercialization of innovative medicinal products and medical devices, helping to minimize the times and maximize the cost efficiency.
Also, we have worked in 15 successful PIPs and 20 ODDs. Our regulatory strategy experts have participated in scientific advices with EMA, as well as National Competent Authorities, such as: PEI, AEMPS, DKMA, CbG, MPA, among others.
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