Drug discovery and development is complex, lengthy, and costly. Regulatory control plays a vital role in the drug development process.. Regulatory control specialists are essential for all phases of drug development, starting from drug discovery and preclinical studies to approval and commercialization of the drug product. A thoroughly monitored regulatory affair brings a unique combination of scientific and management assistance.
Several bioanalytical lab services and pharmaceutical companies have dedicated personnel for regulatory control. This personnel is responsible for technical and strategic advice within a drug development organization. Hence, from bioanalytical testing to drug development strategies, regulatory control is the key to success for a drug development initiative. This article will give you a better understanding of the role regulatory control plays in the drug development process. Let us dive in and understand regulatory control at different phases of drug development.
Lifecycle management
A robust lifecycle management system is crucial for the success of a pharmaceutical product. Managing the product life cycle begins early during the discovery and R&D phase and continues till the expiry of the patent. Regulatory control plays a huge part in the product life cycle by demonstrating control, quality, safety, conformity, and efficacy of the drug product.
R&D and clinical phase
Involving regulatory affairs early in the research phase ensures that sponsors can develop an appropriate clinical trial strategy. Clinical trials range from early proof of concept Phase I and II bioanalytical assays to crucial Phase III clinical trials. Regulatory control must be expert enough to tackle registration and documentation of all phases of clinical trials.
Clinical trials are inherently lengthy and costly projects. The primary responsibility of accelerating drug development timelines falls on regulatory affairs. The Investigational Medicinal Product Dossier (IMPD), Clinical Trial Application (CTA), and Chemical Manufacturing and Control (CMC) data are some vital aspects of the documentation process. Any delays in the documentation process can further stall the completion of clinical trials.
Regulatory control handles all the necessary documentation of IMPD and CTA. Although FDA provides guidelines for IMPD for a pharmaceutical product, an experienced CMC writer can help provide the necessary expertise in completing IMPD and CTA documents.
Market authorization application
Once clinical trials are completed, sponsors focus on obtaining regulatory approval for the pharmaceutical drug. However, the regulatory process can be lengthy and unpredictable. Hence, an experienced regulatory affair team can certainly help in the timely market authorization of the drug product.
Also Read: 7 Benefits Of Partnering with a Bioanalytical Services Lab for Drug Research and Development
Companies should have a submission strategy before applying for market authorization. This authorization protocol must carefully consider all regulatory and logistical issues before submission. Here, regulatory control specialists can provide crucial insights into the implementation of the approval process.
Commercialization
After the regulatory agencies decide that the pharmaceutical product has met all requirements, they grant permission to market the pharmaceutical drug. Companies can then commercially produce the drug and market it to the patient population. However, post-approval modifications will need additional regulatory changes, such as vigilance and quality improvement. Hence, the regulatory team must continue focusing on the product and incorporate the necessary documentation.
