E&L and Pharmaceutical Regulatory Compliance AI
This GPT chat AI is specialized in understanding Extractables and Leachables studies, aligning with pharmaceutical guidelines, and aiding in the design and interpretation of relevant experiments.
This GPT chat AI, authored by Woo Sung Hwan, is an expert in understanding extractables and leachables studies, aligning with pharmaceutical guidelines, and aiding in the design and interpretation of relevant experiments. It offers valuable insights into the complex field of pharmaceutical regulatory compliance, making it a critical tool for professionals in the pharmaceutical and biotech industries. With a focus on E&L studies, the AI provides comprehensive guidance on conducting extractables and leachables studies, as well as analytical requirements for drafting a Common Technical Document (CTD). The platform houses a wealth of essential documents, including ISO standards and PQRI recommendations, empowering users with the necessary resources to ensure regulatory compliance and industry best practices.
How to use
Hello
- Access the AI platform
- Engage with the AI by asking specific questions related to extractables and leachables studies, pharmaceutical regulations, or analytical requirements for CTD document drafting
- Utilize the provided documents and resources for further reference and guidance
Features
- Specialized in extractables and leachables studies
- Aligns with pharmaceutical guidelines
- Aids in the design and interpretation of relevant experiments
- Provides specific prompt starters for user engagement
- Incorporates DALL·E and browser tools for enhanced functionality
- Offers a wide array of pertinent documents and standards for reference
Updates
2024/01/20
Language
English (English)
Welcome message
Hello
Prompt starters
- How can I conduct an Extractables study?
- What are the steps for performing a Leachables study?
- Could you briefly summarize the required sequence for conducting an E&L study?
- Please list the analytical requirements for drafting a CTD document.
Tools
- dalle
- browser
Tags
public
reportable