Clinical Regulatory Services
Modern biotechnology-derived pharmaceutical products are an important part of the modern medical system, but generally high costs place a burden on patients, families, medical providers and insurance companies. The introduction of biosimilars (molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biopharmaceuticals) provide opportunities to improve the healthcare system and reduce costs. However, in most countries and regions, there are still several regulatory and cost barriers to the approval of biosimilars. In order to help customers effectively advance their drug development projects, Creative Biolabs has launched clinical regulatory services to solve safety issues related to drug clinical trials through our extensive experience and sound regulatory framework.
Drug Marketing Supervision
The drug regulatory system is constantly developing and there is a tendency towards global unification. Especially in European and American countries, the guidelines developed by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the WHO stipulate some principles for biopharmaceutical development, including specific requirements for quality, efficiency, and safety assessment. To reduce the barriers to market for a drug, developers must understand the legal requirements of a particular country or region. We can help you develop a regulatory plan during a clinical trial to prevent possible difficulties and challenges, and ensure that your development plan has a compliant commercial process. We can provide the following services:
Fig.1 Clinical Trials in the EU Member States.
Clinical trial application (MRCT / IND / CTA). Clinical trial applications need to provide comprehensive information about research drugs and planned trials to enable regulators to assess the acceptability of conducting research. A clinical trial application is a submission to an applicable radiation regulatory agency or corporate regulatory agency whose purpose is to obtain the necessary permits, approvals, or approvals from that agency to legally distribute the product for human clinical trials on that product.
Application for listing (NDA / ANDA / BLA). We help clients collect and organize data on clinical trials of drugs and use them to submit new drug marketing applications (NDAs), Biologics license application (BLA), or new indication applications to the FDA.
Formulation and optimization of clinical development plans. For the development of drugs that do not meet the clinical needs, clinical research is a crucial link. The purpose is to determine the dosage of drugs suitable for the human body through exploratory clinical trials and confirmatory clinical trials, thereby maximizing the clinical benefit of drugs Risk ratio. Among them, exploratory clinical trials require the highest technical conditions and capital investment. Only through a systematic clinical research implementation plan, scientific trial design, and implementation management, the risk of early clinical development can be reduced and provide credibility data reference for the next phase of drug development.
Over the past two decades, the number and complexity of clinical trials have increased dramatically; at the same time, as electronic systems and records have been used more and more, statistical assessments have improved, improving the quality and efficiency of sponsors' clinical research. Creative Biolabs addresses the challenges of surveillance by helping clients develop monitoring plans, manage significant risks to human subjects and data quality, and in part by leveraging innovations in modern clinical trials. We identify potential risks through assessments of:
The likelihood of errors occurring.
The extent to which such errors would be detectable.
The impact of such errors on human subject protection and reliability of trial results.
Our approach to risk assessment is dynamic, and it is easier to promote continuous improvement in trial behavior and monitoring. Monitoring results should be evaluated to determine if additional measures are needed to ensure human subject protection and data quality across the site. If you need or have questions about our clinical regulatory services, you can contact us for more details.