Date: 12/11/2023
Daewon Pharmaceutical Co., Ltd. Preparing for FDA Quality Management System (QMS) and cGMP Inspection with Provision Consulting Group - From December 4th to 7th, Provision Consulting Group's ("PCG") Co-CEO, Sung Kwon, conducted a comprehensive visit to Daewon Pharmaceutical Co., Ltd. ("Daewon") in South Korea. The purpose was to assess the current status of their Quality Management System (QMS) and compliance with cGMP.
During the visit, a focused consultation addressed key areas:
Systematic establishment and operation of QMS.
Verification of cGMP compliance.
Formulation of strategies for FDA inspection preparedness.
Mr. Sung Kwon said, "We will support their successful preparation for FDA cGMP compliance."
Daewon representatives anticipate that PCG's specialized consulting will further strengthen their QMS and cGMP practices. They expressed determination to leverage this preparation for a successful entry into the U.S. market through FDA approval.
PCG, with its wealth of experience and expertise in FDA approval, QMS establishment and operation, and cGMP compliance, stands as a valuable consulting partner. The collaborative effort with Daewon aims to conclude the FDA approval preparation successfully, laying the groundwork for a triumphant entry into the U.S. market.
<Why is FDA Approval Preparation Essential?>-------------------------------------------------------------
FDA approval is a mandatory step for selling pharmaceuticals in the United States. The FDA imposes stringent standards to ensure the safety and quality of pharmaceuticals sold in the U.S. Consequently, any pharmaceutical without FDA approval cannot be marketed in the country.
Strict adherence to QMS and cGMP is crucial for obtaining FDA approval. QMS represents a systematic set of procedures and methods for managing pharmaceutical quality, while cGMP sets standards for excellent pharmaceutical manufacturing and quality control, covering manufacturing, quality management, storage, and distribution.
FDA approval brings several advantages:
Access to the U.S. market.
Assurance of pharmaceutical safety and quality for U.S. consumers.
Reduction of legal risks by complying with U.S. government regulations.
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