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  • Naksh Solutions  (2)
  • 1
    Online Resource
    Online Resource
    Naksh Solutions ; 2023
    In:  International Journal of Advanced Research in Science, Communication and Technology
    In: International Journal of Advanced Research in Science, Communication and Technology, Naksh Solutions
    Abstract: The field of regulatory affairs (RA) serves as a link between the global pharmaceutical sector and regulators. It was created in response to governments’ desire to safeguard the public’s health by regulating the efficacy and safety of pharmaceuticals, veterinary drugs, medical equipment, pesticides, agricultural chemicals, cosmetics, and other goods. Companies that are in charge of the development, manufacture, testing, and sale of these products aim to guarantee that they deliver safe and efficient goods for the welfare of the general public. Different registration criteria for pharmaceutical products are covered by pharmaceutical drug regulatory affairs. As a result of the demand for superior quality medicine that includes safety and efficacy in the areas of not only pharmacy but also veterinary medicine, medical devices, insecticides, pesticides, agrochemicals, cosmetic, and supplementary medicine, a new profession called pharmacy was created. Additionally, it created a connection between the pharmaceutical corporation and the regulating bodies. Maintaining the appropriateness and accuracy of the product information is another duty assigned to it. And its primary responsibility is to serve as a point of contact for regulatory agencies, providing expertise and regulatory intelligence in translating regulatory requirements into realistic, workable plans, and advising the company on regulatory aspects and the regulatory environment that would affect their proposed projects..
    Type of Medium: Online Resource
    ISSN: 2581-9429
    Language: English
    Publisher: Naksh Solutions
    Publication Date: 2023
    Location Call Number Limitation Availability
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  • 2
    Online Resource
    Online Resource
    Naksh Solutions ; 2022
    In:  International Journal of Advanced Research in Science, Communication and Technology
    In: International Journal of Advanced Research in Science, Communication and Technology, Naksh Solutions
    Abstract: The regulatory bodies are being established in various pharmaceutical industries across the globe which plays a vital role to meet the requirements of legal procedures related to drug development process in a country. The pharmaceutical industry is considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Countries possess their own regulatory authority, which is responsible for enforcing the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, labeling and the product life cycle of pharmaceutical products. In an ever-changing regulatory environment, the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. This article describes the development of the drugs as it is a cumbersome process which includes several months of time, volunteers, and a huge finical investment majorly through the funding process, so it is strictly regulated as per the norms and regulations as given by those individual countries to carry out the drug development which was generally governed by the Drug Regulatory Affairs Personals.
    Type of Medium: Online Resource
    ISSN: 2581-9429
    Language: English
    Publisher: Naksh Solutions
    Publication Date: 2022
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
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