Investigational New Drug
(IND) Application
Navigating the Pathway to Clinical Trials
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
- IND Submission Preparation
- Review of Pharmacology and Toxicology Data
- CMC (Chemistry, Manufacturing and Controls) Support
- Regulatory Submission Management
- Response to FDA Inquiries
- Accelerate Your Clinical Program with BioBoston Consulting
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
All Services
- Quality Assurance and Regulatory Compliance
- Investigational New Drug (IND) Application
- Regulatory Strategy & Submissions
- Investigational Device Exemption (IDE) Application
- Vendor Selection & Qualification
- Project & Risk Management
- Technology Transfer
- Quality Management Systems (QMS)
- Gap Assessment and Remediation
- Funding and Investment Strategies
- Research and Development (R&D)
- Biostatistics and Data Analysis
- Lab Operations and Efficiency
- Medical Writing
- CDMO Vendor Selection Qualification & Oversight
- CRO Selection & Qualification
- CTO Selection & Qualification
- Data Integrity and Software Implementation
- Clinical Operations
- Clinical Trial Monitoring
- FDA Inspection Readiness
- Internal and Supplier Audits
- Regulatory CMC Support
- Qualification and Validation
- GxP Training
- Computer System Validation (CSV)
- Strategic Advising
- Process Optimization
- Health Authority Meeting Support
- Recruitment