Investigational New Drug (IND) Application

Filing a successful Investigational New Drug (IND) application is the critical first step toward initiating clinical trials and advancing your drug development program. At BioBoston Consulting, we provide expert guidance throughout the IND application process, ensuring that your submission meets regulatory requirements to guarantee a timely launch of your clinical trial with success.

Why Use BioBoston Consulting for IND Application Assistance?

Navigating the IND Process with Experts

Our team of seasoned regulatory professionals have years of experience with preparing and filing IND applications for life sciences companies. The complex regulatory landscape and how we help you through the process ensures your application is complete, accurate, and aligned with FDA or global regulatory requirements.

Solutions from Preclinical to Clinical Stages

We support your IND submission from preclinical research through the transition to clinical trials, ensuring that all necessary data, including pharmacology, toxicology, and manufacturing information, is accurately presented and compliant with regulatory standards.

Regulatory Compliance Focus

Our team conducts the IND submission in compliance with FDA requirements. We assist in reducing risks, mitigating possible regulatory issues for your application, and position you to move forward with your clinical program.

Customized IND Strategy for Your Product

We know that not every drug development program is the same. Based on your therapeutic area, our IND support services address what must be seen in your application while highlighting the unique aspects of your product to regulators.

Efficient and Timely Submission

Our team collaboratively works with you to make sure that your IND application is filed quickly and accurately, avoiding delays and letting you move with the least resistance from this stage of development phase to initiating clinical trials.

Our IND Application Support Services Include:

Pre-IND Meeting Support

Supporting preparation for pre-IND meetings with the FDA, developing the meeting strategy, preparing briefing documents and guiding your team through process to ensure productive interactions.

IND Submission Preparation

Full support in IND preparation, collecting preclinical data, CMC info, clinical trial protocols and other required sections.

Review of Pharmacology and Toxicology Data

Collecting and collating results from pharmacology and toxicology studies to confirm that full set of preclinical data necessary for IND is supplied and the reports comply with FDA guidelines.

CMC (Chemistry, Manufacturing and Controls) Support

Assisting with the preparation and submission of CMC data to support the manufacturing process and product quality for regulatory requirements.

Regulatory Submission Management

Managing the submission process, including eCTD (electronic Common Technical Document) formatting, and ensuring that the submission is complete and compliant with FDA requirements.

Response to FDA Inquiries

Support for addressing FDA inquiries or requests and timely response to follow-up information needed to keep the application on track for approval.

Accelerate Your Clinical Program with BioBoston Consulting

Our Investigational New Drug (IND) Application services provide life sciences companies with the expertise and support needed to submit successful IND applications and move forward with clinical trials. Let us help you navigate the regulatory process and achieve your development milestones.

Contact Us Today
Schedule a consultation to learn how BioBoston Consulting can support your IND application needs and help you advance your drug development program