IND Publishing and Submission

With extensive experience of our regulatory team, Creative Biolabs provides pre-IND meeting, IND publishing and submission to help gain IND approval to facilitate clinical trials of your drug candidate. We are committed to providing efficient, professional and cost-effective IND publishing and submission service to help our clients to achieve their goals.

IND Process

Creative Biolabs can provide the following end-to-end IND services from the initial registration and dossier publishing to final submission. We aim to smooth your IND approval and promote your drug development.

• ✔ Registration with CTSC
• ✔ Preparing IND package including Cover letter, IND, 1571, 1572 form and certification form 3674.
• ✔ Assembling and binding volumes
• ✔ Submission

Publishing and Submission

To support the dossier package submission across the globe, Creative Biolabs is dedicated to comprehensive services of global regulatory publishing and submission formats including electronic Common Technical Document (eCTD), non-eCTD and paper. We offer document compilation and publishing, and dossier dispatches through specific regulatory publishing and submission software. Adhering to various regulatory guidelines, Creative Biolabs is your trusted partner for multiple submissions within agreed timelines, which has proven to be cost-effective.

• Capturing and documenting the HA requirements timely
• Paper, NeeS and eCTD available
• Developing knowledge repository for regional requirements globally
• Periodic updates and training on the changing global regulatory requirements
• Continuous project monitoring
• Periodic quality check for effective time management
• Detailed tracker creation for all the version changes made through publishing lifecycle

Highlights

• ✔ Qualified publishing and submission experts
• ✔ High-quality publishing that enables your organization to focus on core business functions
• ✔ Submission roadmap from original compiling submissions to maintaining lifecycle, to supporting regulatory resource
• ✔ Two-stage quality check process
• ✔ Transparent processes.

With an expert regulatory publishing and submission team, Creative Biolabs caters value-added support for dossier package submission both in paper as well as CTD formats. We decode region specific technicalities to streamline submissions. Please contact us for more information and a detailed quote.