Tanner-Pharmaceutical Regulation Expert
Powering Compliance with AI
Could you explain the recent updates to the ICH guidelines?
What are the key differences between FDA and ICH regulations regarding clinical trials?
How should pharmaceutical companies prepare for an FDA inspection?
Can you provide an overview of the ICH Q10 guideline on pharmaceutical quality systems?
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Introduction to Tanner
Tanner is a specialized version of ChatGPT, meticulously designed to serve as an expert resource within the pharmaceutical industry, with a focus on ICH and FDA guidelines. The model has been tailored to provide precise and up-to-date regulatory guidance, ensuring compliance in drug development and manufacturing processes. Tanner's functionality is underpinned by advanced browsing capabilities, enabling access to the latest guidelines from authoritative sources such as www.ich.org and www.fda.gov. The design purpose of Tanner is to act as a knowledgeable consultant in pharmaceutical regulation, offering detailed answers and clarifications that are backed by specific regulatory references. Powered by ChatGPT-4o。
Main Functions of Tanner
Regulatory Guidance
ExampleFor instance, when a pharmaceutical company needs to understand the specific ICH guidelines applicable to the stability testing of new drug substances, Tanner can provide detailed interpretations of ICH Q1A(R2) including the necessary test conditions and time points.
ScenarioA pharmaceutical company is preparing for the stability testing phase of a new drug and needs to ensure compliance with international standards.
Compliance Assurance
ExampleIf a company is uncertain about the requirements for electronic records and electronic signatures, Tanner can outline the specific provisions of 21 CFR Part 11, explaining the criteria for system validation, audit trails, and electronic submissions.
ScenarioA biotech startup is transitioning from paper-based to electronic records and must comply with FDA electronic documentation standards.
Update Alerts
ExampleWhen new amendments are made to the FDA's policy on generic drug approvals, Tanner can provide an immediate update and detailed analysis of how changes might impact ongoing and planned submissions.
ScenarioA pharmaceutical firm is in the process of submitting an ANDA (Abbreviated New Drug Application) and must stay informed about any regulatory changes that could affect their submission.
Ideal Users of Tanner Services
Pharmaceutical Companies
This group consists of organizations involved in drug development and manufacturing. They benefit from Tanner's services due to the need for stringent adherence to regulatory guidelines to avoid costly delays and ensure market access.
Regulatory Affairs Professionals
Individuals who manage the regulatory process for their companies throughout the drug lifecycle, from clinical trials through post-marketing. They rely on Tanner for up-to-date regulatory information and strategic compliance advice.
Research and Development Scientists
Scientists and researchers involved in formulating and testing new drugs can use Tanner to stay informed about the latest regulatory requirements that might impact their research protocols and outcomes.
How to Use Tanner
Visit yeschat.ai
Start by visiting yeschat.ai for a complimentary trial, no login required, and without the need for a ChatGPT Plus subscription.
Select Tanner
Choose Tanner from the available GPT options to access specialized knowledge in pharmaceutical regulations, including ICH and FDA guidelines.
Define your query
Clearly formulate your query related to pharmaceutical regulations. Tanner is designed to handle complex inquiries and provide detailed, specific responses.
Submit your question
Enter your question in the provided text field. Tanner will process the information and generate a response that is precise and rich in content.
Use follow-up questions
For further clarification or deeper insight, use follow-up questions. Tanner can handle a detailed dialogue to ensure comprehensive understanding.
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Detailed Q&A About Tanner
What types of guidelines can Tanner provide information on?
Tanner specializes in providing detailed explanations and guidance on ICH and FDA regulatory frameworks. It can interpret and explain specific clauses and requirements from these guidelines.
How can Tanner assist in pharmaceutical research?
Tanner can aid researchers by providing regulatory insights, helping them ensure their study designs comply with current pharmaceutical regulations and guidelines. This includes advice on clinical trials, drug submissions, and safety monitoring.
Is Tanner capable of keeping up with changes in regulations?
Yes, Tanner's browsing capability allows it to access and incorporate the latest amendments and updates in regulatory guidelines from official sources such as www.ich.org and www.fda.gov.
Can Tanner assist with training in regulatory affairs?
Absolutely. Tanner can serve as an educational tool, offering detailed explanations and training support on various aspects of pharmaceutical regulations and compliance.
What makes Tanner different from other AI tools?
Unlike generic AI tools, Tanner is specifically tuned for the pharmaceutical industry, focusing on regulatory guidelines and offering precise, expert-level responses tailored to professionals in the field.