Pre-IND Meeting

With extensive experience of pharmaceutical development, regulatory strategy and affairs experience, Creative Biolabs provides IND regulatory services to facilitate your IND approval including pre-IND meeting which spans a broad range of therapeutic categories.

Background

For the drug development, pre-IND meeting is a critical tool to discuss the needs and challenges specific to the general product development, nonclinical testing, manufacturing information, protocol design or other regulatory questions defined in the Code of Federal Regulations (21 CFR 312.82). We are dedicated to minimizing the potential regulatory risks and better positioning your products for ultimate commercial success. Creative Biolabs expects to provide our clients with the following critical information to guide their drug development process.

• ✔ Sufficient information for a protocol design, the endpoints, measurements, etc. etc.
• ✔ Valuable suggestions on time, cost, order and risks of drug development.

Capabilities

Creative Biolabs can provide the following services about pre-IND meeting package and presentation preparation to promote your drug development and offer constructive suggestions for your program.

• ✔ Meet with you to prepare for an FDA pre-IND Meeting;
• ✔ Prepare a pre-IND meeting request (including a draft of brief product description, objectives, expected outcomes, proposed agenda, preliminary questions, sponsor attendees and proposed dates for the pre-IND meeting);
• ✔ Prepare a Briefing Book/Document that includes a rationale for recommended clinical studies and other FDA pre-IND meeting guidance 30 days prior to the meeting with finalized questions and information;
• ✔ Review FDA response to the briefing package and prepare pre-IND Meeting presentation including outstanding questions;
• ✔ Give your company presentation at the meeting;
• ✔ Review the FDA pre-IND feedback and provide strategic advice for advancing your product.

Fig.1 Timeline of pre-IND meeting.

Highlights

Pre-IND meeting is a critical milestone highly recommended by agencies and industries. With the goal of obtaining the approval of drug development plans and future clinical trials from the agencies, Creative Biolabs aims to try our best to benefit our clients and promote the approval of IND.

• ✔ Ensure early feedback from agency
• ✔ Help to fine-tune your development strategy
• ✔ Promote relationship building with agency
• ✔ Reduce time to market.

As pre-IND experts, Creative Biolabs is dedicated to offering our clients regulatory guidance throughout the entire pre-IND process. We are committed to working with you from the initial pre-IND meeting request to the preparation for the meeting and implementation of the meeting. To help you make full use of this key milestone, please feel free to contact us.