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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE NUMBERDATE(S) OF INSPECTION10 Waterview Blvd., 3rd Floor Parsippany, NJ 07054 (973)3314900 Fax:(973)331496912/5/20171/8/2018*
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Gather all necessary documentation related to your pharmaceutical product.
02
Ensure all product information is accurate and complies with regulatory standards.
03
Complete any required forms specified by the Office of Pharmaceutical Quality.
04
Include a comprehensive summary of the product's development, manufacturing process, and quality control measures.
05
Submit the application through the designated electronic portal or mailing address.
06
Monitor the status of your submission and respond promptly to any inquiries from the Office.

Who needs office of pharmaceutical quality?

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Pharmaceutical companies seeking to ensure the quality of their products.
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Manufacturers looking to comply with regulatory standards set by health authorities.
03
Researchers developing new pharmaceutical formulations.
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Regulatory affairs professionals managing submissions to health agencies.
05
Quality assurance teams overseeing compliance and product safety.
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The Office of Pharmaceutical Quality (OPQ) is a division within the FDA responsible for ensuring the quality of pharmaceutical products through regulatory oversight and guidance.
Pharmaceutical manufacturers and organizations involved in the development and production of drug products are required to file with the Office of Pharmaceutical Quality.
To fill out the Office of Pharmaceutical Quality submission, you must follow specific guidelines set by the FDA, including providing detailed information about the drug's production process, quality control measures, and compliance with regulatory standards.
The purpose of the Office of Pharmaceutical Quality is to ensure that pharmaceutical products are of high quality, safe, and effective for consumers by regulating manufacturing practices and conducting thorough reviews.
Information that must be reported includes the manufacturing process, quality assurance protocols, test results, stability data, and any other relevant details that show compliance with FDA regulations.
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