Maximixe Savings, Bulk Pricing for Type B and Type C meetings!
What we do:
At RegQ Consulting, we specialize in facilitating communication between the pharmaceutical and medical device industries and the Food and Drug Administration (FDA). Our team, composed of former FDA employees, bring strategic insights and expertise to enhance your communications with regulatory agencies.
Expertise You Can Trust
Our team consists of professionals with in-depth experience at the FDA, ensuring that you receive insider knowledge and practical advice
Customized Solutions
We understand that every client is unique. Our approach is tailored to fit your specific needs and objectives. Gain insightful feedback and strategic direction through our regulatory meeting services.
Real Results
Our team has a track record over 500 regulatory meetings collectively and we are committed to helping clients achieve favorable outcomes in their regulatory communications.
Regulatory Meetings We Support with FDA:
Type A Meetings
Type A Meetings
Type A Meetings
TYPE A meetings are crucial for advancing stalled product development or addressing urgent safety issues. They ensure compliance and foster sponsor-regulatory collaboration. Key reasons include:
- Dispute Resolution: Conducted per 21 CFR 10.75, 312.48, 314.103, for sponsor appeals above the division level, per FDA guidance.
- Clinical Holds
TYPE A meetings are crucial for advancing stalled product development or addressing urgent safety issues. They ensure compliance and foster sponsor-regulatory collaboration. Key reasons include:
- Dispute Resolution: Conducted per 21 CFR 10.75, 312.48, 314.103, for sponsor appeals above the division level, per FDA guidance.
- Clinical Holds: Initiate to resolve or respond to clinical hold concerns, especially when development stalls and new pathways are needed.
- Special Protocol Assessment: Requested after receiving an FDA Nonagreement SPa, to clarify next steps.
- Post-Action Meetings: Request within 3 months of FDA action (excluding approvals) to discuss implications and future plans.
- Refusal-to-File Letters: Must request within 30 days for filing over protest, per 21 CFR 314.101(a)(3).
Type B Meetings
Type A Meetings
Type A Meetings
These meetings allow discussion of the overall development plan, including clinical data requirements and product performance expectations. We guide you in articulating your product vision and developing data-driven presentations that resonate with FDA officials. Type B meetings are key in drug development and approval, held at various s
These meetings allow discussion of the overall development plan, including clinical data requirements and product performance expectations. We guide you in articulating your product vision and developing data-driven presentations that resonate with FDA officials. Type B meetings are key in drug development and approval, held at various stages to facilitate sponsor-FDA discussions.
Key types include:
- Pre-IND Meetings: Discuss clinical plans before submitting a new drug application.
- Pre-EUA Meetings: Address steps for emergency use of unapproved products.
- Pre-NDA/BLA Meetings: Occur before formal NDA/BLA submission, ensuring concerns are addressed.
- Post-Action Meetings: Discuss outcomes and next steps after regulatory actions.
- EMS Discussions: Focus on risk mitigation strategies outside regular reviews.
- Development Meetings: For products with special designations, ensuring milestone achievement.
Type C Meetings
Type A Meetings
Type C Meetings
Type C meetings are a flexible category of discussions in the drug development and review process. Unlike Type A and B meetings, which have specific goals, Type C meetings include any meetings outside those defined types.
These discussions are vital for product development, offering a space for sponsors and the FDA to exchange ideas on var
Type C meetings are a flexible category of discussions in the drug development and review process. Unlike Type A and B meetings, which have specific goals, Type C meetings include any meetings outside those defined types.
These discussions are vital for product development, offering a space for sponsors and the FDA to exchange ideas on various topics. Key aspects of Type C meetings include:
- Broader Scope: They cover diverse topics related to product development and review, allowing for discussions that don't fit into other categories.
- Early Biomarker Consultations: They often focus on early talks about using biomarkers as surrogate endpoints, especially when a biomarker will serve as the primary basis for approval and hasn’t been used this way before.
- Regulatory Guidance: They serve as a valuable resource for sponsors seeking advice on regulatory requirements, tackling challenges, and ensuring their development plans meet FDA standards.
- Participating in Type C meetings helps developers collaborate with regulators, accelerate development, and better understand the regulatory landscape for innovative therapies. This proactive engagement can improve the chances of successfully launching new treatments.
Type D Meetings
Compliance Meetings
Type C Meetings
Type D meetings are vital in drug development regulation, focusing on specific issues at key decision points. They concentrate on one or two main topics, allowing sponsors to receive critical feedback on significant project-impacting issues. Sponsors may request Type D meetings for follow-up questions, targeted input on narrow issues, or
Type D meetings are vital in drug development regulation, focusing on specific issues at key decision points. They concentrate on one or two main topics, allowing sponsors to receive critical feedback on significant project-impacting issues. Sponsors may request Type D meetings for follow-up questions, targeted input on narrow issues, or about innovative strategies that don't need detailed guidance. These meetings should cover no more than two issues; complex topics warrant a Type C meeting. If discussions involve multiple disciplines or are broadly complex, the FDA may escalate to a Type B or C meeting, with sponsors notified and free to withdraw or accept the change. Effectively using Type D meetings helps sponsors gain guidance, make informed decisions, and stay on track with development while maintaining a strong regulator partnership.
Compliance Meetings
Compliance Meetings
Compliance Meetings
Facing a Form 483 after an inspection can be challenging. We provide regulatory meeting support to help your team prepare a clear, organized response strategy and engage FDA with confidence.  
If FDA requests a meeting to discuss your response, we help you prepare for that discussion, align on key messages, and structure the information
Facing a Form 483 after an inspection can be challenging. We provide regulatory meeting support to help your team prepare a clear, organized response strategy and engage FDA with confidence.  
If FDA requests a meeting to discuss your response, we help you prepare for that discussion, align on key messages, and structure the information needed to support your corrective action plan.  
Our focus is to help your team communicate clearly, address each observation thoughtfully, and present a remediation approach grounded in investigation, CAPA, and objective evidence. 
Pre-Sub Meetings
Compliance Meetings
Compliance Meetings
We specialize in facilitating Presubmission meetings with the FDA, ensuring your medical device development process is both streamlined and compliant Our tailored services are designed to provide you with comprehensive support at every stage of your journey towards regulatory approval.
Our Services:
We work with your team to achieve the following objectives:
MEETING PREPARATION:
- Tailored strategies to ensure your team is well-prepared for FDA discussions.
- Comprehensive briefing materials highlighting key points and objectives.
MEETING PACKAGE PREP:
- Development of clear and concise meeting packages that facilitate productive conversations with regulatory officials
- Expert guidance on what information to present and how to present it.
MEETING FACILITATION:
- On-site and teleconference support during FDA meetings to help navigate the discussion and address questions in real-time.
- Follow-up strategies to ensure that all points discussed are documented and actionable.
