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Regulatory oversight and guidance of the drug development process is vital to help ensure pharmaceutical companies are appropriately monitoring the safety and efficacy of drugs.
FREMONT, CA: The pharmaceutical business operates under a plethora of regulations, and organizations have to comply with the intricate regulatory system for a very good reason, that is patient safety. When introducing a new drug to the market, the regulatory body has to be 100 percent sure that the patient population is not at risk. Regulatory compliance is a concern during the entire drug development process, from discovery to preclinical development, clinical research, and manufacturing. However, the implications, focus, and efforts to ensure compliance rise dramatically, the closer organizations get to the patient. Organizations need to make sure that all good practice regimes are managed, and scientific data collection is conducted to meet the relevant regulations.
The number of regulatory affairs involvement at the early stage may be minimal but is of long-term benefit. Timely involvement and continuity matter a lot. The regulatory guidance evolves with the technology as new data becomes available about the disease status and its prevention or treatment. Regulatory professionals are poised to sail this path. Engaging in regulatory affairs early in development will mitigate the risk of delays in later development stages. Their familiarity with the regulations technology, product development life cycle, and the company’s business approach provides the view with which to scrutinize early activities in consideration of the goal of licensure and commercialization.
Regulatory agencies have minimal oversight of drug discovery studies, yet do provide certain requirements and clear documentation to achieve milestone during this process. In conclusion, although regulatory oversight is less stringent during the drug discovery phase, regulatory requirements must be considered during the early development of drug products. Following the drug, the discovery phase is the preclinical phase, which evaluates the safety factors of the drug as well as drug behavior in the host organism.
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