Local QP Support for Batch
Ensure Quality and Compliance from Manufacturing to Market While Navigating Regulatory Challenges with Our Expert QP Solutions
Ensure Quality and Compliance from Manufacturing to Market While Navigating Regulatory Challenges with Our Expert QP Solutions
We offer top-notch local Qualified Person (QP) support for batch release; ensuring pharmaceutical products meet regulatory standards with precision and expertise. Our services are tailored to your market’s specific needs, facilitating seamless and compliant batch release processes.
When a pharmaceutical product is released into a clinical trial or the market in the European Union, it must be certified by a Qualified Person (QP). This process, known as a QP release, occurs after the drug is released. Pharmaceutical products imported into the EU from outside the EU are also subject to QP certification and release. Zenovel offers QP services, and it is recommended to explore their range of activities and benefits.
The QP is responsible for ensuring that pharmaceutical products meet high standards and quality attributes, regardless of the manufacturing location. According to Article 48 of Directive 2001/83/EC, the QP must certify that each batch of pharmaceutical products complies with the established quality standards. Before a product is released to the market or used in clinical trials, the QP must verify that the product adheres to GMP guidelines and that all necessary documentation is authorized. Additionally, the QP ensures that the distribution of pharmaceutical products complies with both local regulations and international laws in the respective countries.
Extensive knowledge and experience in pharmaceutical quality and regulatory affairs.
In-depth understanding of local regulations and market
Dedicated to maintain highest quality standards compliance.
Ensure products are safe and effective.
Work closely with clients
Provide personalized support and solutions.
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