In:
Journal of Pharma and Drug Regulatory Affairs, MAT Journals, Vol. 5, No. 1 ( 2023-06-30), p. 14-21
Abstract:
Regardless of the size of your company or the stage of your product development, regulatory filings can be difficult. When creating a regulatory submission for approval, there are several steps and room for error. On the other hand, project leaders who are knowledgeable about regulatory submissions can support the effort to foresee, avoid, reduce, and handle these difficulties. In truth, corporations may be able to handle a lot of these issues. The careful navigation of intricate restrictions established by international health authorities is required for the commercialization of novel pharmaceuticals. Extensive internal and external stakeholder interactions are required for the production of pharmaceuticals, as well as cross-functional team coordination in areas including R & D, QA, clinical research, safety, manufacturing, supply chain, marketing, and so forth. At every step of development, companies are in charge of ensuring the security and effectiveness of their medications for human use. To do this, documentation and dossiers must be shared with health authorities regularly. The R & D divisions, CROs, and regulatory agencies of several biopharma, consumer healthcare, and medical device businesses have difficulties in this field. For all businesses to file regulatory filings on time, correctly, and at the appropriate level, there must be clear criteria.
Type of Medium:
Online Resource
ISSN:
2582-3043
DOI:
10.46610/JPDRA.2023.v05i01.002
Language:
Unknown
Publisher:
MAT Journals
Publication Date:
2023
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