The development of clear and accurate regulatory strategy is crucial in ensuring the quality of R&D and expediting product launches. Drawing from our extensive experience in industrial product development and regulatory evaluation, the Regulatory Strategy Team at TriApex offers clients services in three areas: regulatory strategy, registration application, and technical consulting/training.
The core team possesses extensive experiences in drug development from industries and project review from regulatory authority. We have a deep understanding of the rules and critical points during the drug development, thus can evaluate the project from multiple dimensions to accelerate R&D process and improve application quality.
Our team has extensive practical experiences in drug development and successful registration application, covering various types of projects such as new chemical entity (NCE), monoclonal/bispecific/multispecific antibodies, oncolytic viruses, cell and gene therapies, biosimilars, generic drugs, etc. With such expertise, we can provide customized research plan and risk assessment for specific product.
Regulatory Strategy and Registration Application Pathway Planning
We closely monitor the updates of regulations and guidelines, as well as follow up on the development of emerging therapies in the field. With a deep understanding of the products and competitive landscape, our goal is to assist clients in creating scientific, feasible, and practical regulatory strategy and registration application pathways. This includes developing strategies for product development, clinical research and registration application, breakthrough therapy designation (BTD), combination therapies, conditional approvals, and priority review, etc.
Application Dossier Writing, Review and Submission
In accordance with domestic and global regulations and guidelines both domestically and internationally, we provide customized compilation, writing, or review of application dossier. Besides that, we can also assist the clients in the submission of pre-IND, IND, EOP1/EOP2, pre-NDA, and NDA/BLA applications.
Target product profile (TPP), Regulatory Compliance and Risk Management Consulting
The scope of our services further includes TPP design, background research on interested indications, training on regulations and technical guidelines, compliance consulting, and risk management advice during drug research and development.