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.
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.
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.
Fig.1 Timeline of pre-IND meeting.
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.
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.
For lab research only, cannot be used for any clinical use.