The Importance of Preclinical Studies in Regulatory Submissions

The process of developing drugs usually involves three key stages: discovery, preclinical development, and clinical trials. Within this process, preclinical research is extremely important as it provides essential information regarding the safety, effectiveness, and pharmacological characteristics of a product before it is tested on humans. These studies are conducted before human clinical trials commence and are pivotal in the regulatory approval process for new drugs and medical equipment.


The main goal of preclinical investigations is to ensure the safety of the product in animal models and detect any potential harmful effects or toxicity. Subsequently, this data is utilized to determine the safe initial dose for human clinical trials and to develop suitable clinical trials that will continue to assess the efficacy and safety of the product.etics and pharmacodynamics of the product. This includes how the body absorbs, distributes, metabolizes, and excretes the product, as well as the way it interacts wit

Moreover, preclinical research furnishes critical details on the pharmacokinh other drugs or substances.

Preclinical studies are essential in the approval process of Investigational New Drug (IND) applications, which are submitted to regulatory agencies like the US Food and Drug Administration (FDA) to request permission to conduct human clinical trials of a new drug or biological product.

Regulatory compliance during preclinical studies is essential for generating reliable and accurate data that can support regulatory submissions. Compliance with Good Laboratory Practices, Institutional Animal Care and Use Committee approval, ethical considerations, regulatory agency guidelines, data management, and adverse event reporting are crucial for meeting regulatory standards.

Following preclinical studies, regulatory affairs are necessary to facilitate the clinical trial process, which involves tasks such as securing approval for Investigational New Drug (IND), Institutional Review Board (IRB) approval, and creating the clinical trial protocol.

DDReg, as a globally leading Pharmaceutical Regulatory Consulting Organization, can help sponsors and investigators navigate the complex regulatory landscape during preclinical trials to ensure that the study is conducted in a compliant and efficient manner. As part of its diverse portfolio, it provides support in developing customized and tailored preclinical strategies to its customers for investigational new drug applications. The regulatory team provides end to end support in preclinical dossier compilation to cover all crucial components that are required for the application.

In addition to regulatory support, DDReg also provides regulatory intelligence and advisory services, medical/clinical/regulatory reports, pharmacovigilance- including RMP, aggregate report, ICSR processing and submission, QPPV services etc- labelling, publishing. With the regulatory intelligence of agencies in over 120 countries including regulated and emerging markets, and deep subject matter expertise, DDReg has provided its customers with hand-help support in all domains along all stages of product life cycle development. These products include generics, OTC, biologics, biosimilars, vaccines, consumer products, and medical devices. 


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