IND Regulatory Services - Creative Biolabs

Navigating the drug development process from early stage discovery to clinical stage is complex and expensive. To help your pre-clinical development be in compliance with global regulations and to help gain IND approval for your drug candidates, Creative Biolabs offers a comprehensive series of IND regulatory services, including strategy consulting, medical writing and translation, pre-IND meeting, IND publishing and submission, post-IND maintenance.

Our End-to-end Regulatory Solution

To guide our clients to gain a successful Investigational New Drug application (IND), our regulatory service team is dedicated to the whole process of drug development including study design, document preparation, etc. Our end-to-end IND regulatory solutions aim to meet the requirements of clients’ pre-IND and IND submissions to ensure compliance with a broad range of regulations and protocols issued by global health authorities.

Fig.1 Complete IND regulatory service package. (Creative Biolabs Original) Fig.1 End-to-end solution of IND regulatory service.

Individual Capabilities

Navigational medical products often fail to overcome complex scientific and regulatory barriers in clinical trials because of regulatory problems. An experienced partner can guide you through these difficult processes, which can greatly improve your success rate, while reducing development time and cost. To successfully help our clients launch their drugs in clinical stage and market and maximize the value of their assets, Creative Biolabs offers the following modules to enable our clients to understand and efficiently manage the diverse regulatory requirements. Please visit individual modules to check your desired requirements.

Strategy Consulting

To provide regulatory strategy consulting service to gain IND approvals for clinical testing

Medical Writing and Translation

To offer support for dossier documents to ensure submission readiness

Pre-IND Meeting

To promote your drug development and provide constructive suggestions for your program

Post-IND Maintainance

To offer protocol amendments, information amendments, safety amendments and annual reports to maintain IND

IND Publishing and Submission

To provide efficient, professional IND publishing and submission service to help our clients to achieve their goals

Highlights

✔ Prepare and submit all necessary documents;
✔ Obtain, review, edit, and assemble the IND information package;
✔ Prepare or update the clinical Investigator’s Brochure (IB);
✔ Assemble the IND study protocol and offer documents related to the four basic clinical sections—clinical protocol, investigator data, facility data, and Institutional Review Board data;
✔ Fully participate in discussions with the FDA during pre-IND and IND meetings;
✔ Help our clients to respond to FDA meeting reviews and comments.

Please contact us for a detailed communication about your requirements. An integrated end-to-end solution is recommended to ensure no gaps between each step, and individual module is also welcomed. Creative Biolabs is committed to serving our clients always the best.