Drug Submissions Investigational New Drug (IND) Submission Services

    Obtaining Investigational New Drug (IND) approval from the FDA is a pivotal milestone in your drug development journey. At The FDA Group, we understand the complexities and challenges of this process. Our expert team is dedicated to guiding you through every step, ensuring a smooth path from pre-IND planning to successful submission and beyond.

    Contact us »

    Your gateway to clinical trials starts here

    The Investigational New Drug application is your critical first regulatory milestone—the document that convinces the FDA your drug is safe enough for human testing. A well-crafted IND does more than gain approval; it sets the strategic direction for your entire development program, establishes FDA rapport, and can accelerate or impede everything that follows.

    Yet IND preparation challenges even experienced teams. Requirements span chemistry, manufacturing, nonclinical studies, clinical protocols, and regulatory strategy. Each section must tell a coherent story while meeting specific technical requirements. Deficiencies trigger clinical holds that can delay programs by months and burn through capital.

    Our IND specialists—including former FDA reviewers who've evaluated hundreds of applications—know exactly what makes INDs successful. We've guided everything from novel biologics to repurposed small molecules through the IND process, achieving first-cycle approvals and avoiding preventable holds.

    fda-pillar-guides-hero

     

    Our IND application services include:

    • Pre-IND strategy development and regulatory pathway assessment
    • Pre-IND meeting request preparation and FDA engagement
    • Chemistry, Manufacturing, and Controls (CMC) section development
    • Nonclinical pharmacology and toxicology data compilation
    • Clinical protocol and investigator's brochure review
    • Risk assessment and mitigation strategies
    • Form FDA 1571 and 1572 preparation
    • Electronic Common Technical Document (eCTD) formatting
    • Module compilation and cross-referencing
    • FDA submission and correspondence management
    • Clinical hold response strategies
    • IND amendment and annual report preparation
    • Safety report compilation and submission

    Key IND components we develop:

    • Module 1: Administrative information and forms
    • Module 2: Comprehensive summaries (CTD)
    • Module 3: Quality/CMC documentation
    • Module 4: Nonclinical study reports
    • Module 5: Clinical protocols and information

    Experienced IND consultants

    Unlike other regulatory consulting firms whose consulting bench may consist of less-experienced experts, each of our IND consultants has an extensive track record of success, ensuring you get the knowledge and expertise you need to successfully gain market clearance. Simply put, we deliver better talent, faster and more cost-effectively than traditional firms.

    Industry and former FDA professionals

    Our consulting network contains a mix of regulatory professionals, some of whom are former FDA personnel. Their unique understanding of the FDA’s review process and expectations enables us to handle our clients' submissions with the utmost expertise and attention to detail. Our insider perspective and decades of combined experience give us the edge to help our clients navigate the complex IND submission process.

    Unparalleled client success and satisfaction

    Our 95% client success rate (right resource, first time) and 97% client satisfaction rate speak for themselves. Our clients trust in our expertise to guide them through the submission process. With us as your consulting partner, you'll get a refreshingly personalized approach, clear communication, and attention to detail — three elements that are becoming increasingly hard to find. It's what makes us the preferred choice for IND submission support.

    Regulatory considerations for IND applications Why you need an expert regulatory consultant

    The path to getting a drug to the clinic is rarely straightforward. It's often filled with unexpected challenges and regulatory hurdles that can significantly impact your development timeline and budget. An expert IND regulatory consultant brings invaluable guidance to this complex journey. Over the many years we've spent helping prepare INDs, we've seen companies realize they need expert help in a number of areas, including but not limited to the following:

    • Managing the Many Moving Parts: The regulatory application process involves numerous interconnected elements. Our team understands these intricacies and ensures seamless alignment and integration across all aspects of your IND submission.

    • Accelerating Time to Market: A successful IND submission is a key milestone in your drug development journey. Getting it right the first time can significantly accelerate your time to market. Our experts help you navigate potential pitfalls, optimizing your submission for a smoother review process.

    • Staying Current in an Evolving Regulatory Environment: Regulatory requirements are constantly evolving, and staying up-to-date can be a full-time job in itself. Our regulatory advisory team tracks these changes across various regions, ensuring your IND submission meets the latest standards and best practices.

    • Developing a Comprehensive Regulatory Strategy: Beyond the IND submission itself, our consultants help develop a regulatory strategy for your product's entire lifecycle. This forward-thinking approach aligns your current submission with your long-term development and commercialization goals.

    • Interfacing with the FDA: Effective communication with regulatory agencies is crucial for a successful IND submission. Our team has extensive experience interfacing with the FDA and other relevant agencies, ensuring clear, productive dialogues that support your development goals.

    • Providing End-to-End Support: From developing your initial regulatory strategy to preparing registration documents for market approval, our team offers comprehensive support throughout your product's journey. This end-to-end approach ensures consistency and efficiency across all regulatory interactions.

    Contact us »

    IND Services Pre-IND Planning and Strategy

    Laying the groundwork for a successful IND submission is critical. Our pre-IND planning and strategy services include:

    • Comprehensive assessment of your drug development program: We conduct a thorough review of your entire drug development program, including preclinical data, manufacturing processes, and clinical development plans.
    • Gap analysis to identify and address potential issues early: Our experts perform a detailed gap analysis, comparing your current data and documentation against FDA requirements. We identify any potential issues or shortcomings in your program and develop strategies to address them proactively, saving time and resources in the long run.
    • Development of a robust pre-IND meeting strategy: We help you prepare for and make the most of your pre-IND meeting with the FDA. This includes drafting a comprehensive pre-IND meeting package, developing targeted questions to gain valuable FDA feedback, preparing your team for the meeting and potential FDA inquiries,a and post-meeting analysis and action plan development.

    Contact us »

    IND Services IND Application Preparation

    Our team guides you through the IND application process:
    • Documentation compilation: We gather and review all required documents, ensuring completeness and accuracy.
    • FDA form preparation: We accurately complete Forms FDA 1571 (IND application), 1572 (Investigator Statement), and 3674 (ClinicalTrials.gov Certification).
    • Investigator's Brochure and protocol development: We create clear, comprehensive documents summarizing relevant data and detailing study designs.
    • CMC data assistance: We organize and present your Chemistry, Manufacturing, and Controls data to meet FDA expectations, covering drug substance/product information, manufacturing processes, and stability data.

    Contact us »

    IND Services Nonclinical and Clinical Data Review

    We ensure your existing data supports your IND application:

    • Pharmacology and toxicology evaluation: We analyze preclinical studies for quality, completeness, and GLP compliance, identifying any safety concerns or needs for additional studies.
    • Human experience data review: If applicable, we examine previous clinical trials, compassionate use cases, and relevant literature.
    • Data gap identification: We pinpoint areas needing additional data and develop efficient strategies to address them, including targeted studies or scientific rationales.

    Contact us »

    IND Services Regulatory Writing and Submission

    Our regulatory experts craft a clear, compelling IND application:

    • IND section preparation: We draft all components, including the introductory statement, investigational plan, CMC section, and clinical protocols.
    • Quality control: Our rigorous process involves multiple expert reviews, cross-referencing, and regulatory compliance checks.
    • Electronic submission: We manage the entire process, from formatting documents to eCTD specifications to submission through the FDA's Electronic Submissions Gateway.

    Contact us »

    IND Services Post-Submission Support

    We provide ongoing assistance throughout the review process:

    • FDA communication management: We act as a liaison, handling all FDA interactions promptly and professionally.
    • FDA meeting preparation: Should the FDA request a meeting, we prepare briefing documents, develop presentations, and coach your team on effective communication.
    • Response assistance: If the FDA requires additional information, we analyze requests, coordinate data gathering, and draft clear, concise responses addressing all concerns

    Contact us »

    Click to expand A sample of specific IND consulting activities

    Below are just some of the specific IND activities we assist with. Contact us to discuss your specific preparation and submission needs.

    • Gap Analysis of Preclinical Data
      • Review existing toxicology studies for GLP compliance
      • Assess pharmacokinetic data for completeness
      • Evaluate genotoxicity and carcinogenicity studies if applicable
      • Identify any missing studies required for IND submission
    • CMC Documentation Review
      • Analyze drug substance and drug product specifications
      • Review stability data and proposed expiration dating
      • Assess manufacturing process descriptions for completeness
      • Evaluate analytical method validation reports
    • Clinical Protocol Development
      • Draft detailed study designs for Phase 1 trials
      • Develop inclusion/exclusion criteria for study subjects
      • Create dosing schedules based on preclinical data
      • Design safety monitoring plans and stopping rules
    • Investigator's Brochure Preparation
      • Compile and summarize all relevant preclinical and clinical data
      • Develop clear, concise descriptions of the investigational drug
      • Create appropriate tables and figures to present data effectively
    • FDA Form Completion
      • Fill out Form FDA 1571 (IND Application)
      • Assist investigators in completing Form FDA 1572 (Statement of Investigator)
      • Prepare Form FDA 3674 (Certification of Compliance with ClinicalTrials.gov Requirements)
    • Electronic Submission Preparation
      • Convert all documents to PDF format according to FDA specifications
      • Create XML backbone for eCTD structure
      • Generate and test hyperlinks within the submission
      • Validate the eCTD against FDA technical specifications
    • Pre-IND Meeting Support
      • Draft pre-IND meeting request letter
      • Prepare pre-IND briefing document
      • Develop presentation slides for the meeting
      • Conduct mock Q&A sessions to prepare the team
    • Regulatory Strategy Development
      • Assess potential for expedited program designations (Fast Track, Breakthrough Therapy)
      • Plan for future NDA submission requirements
      • Develop strategies for addressing potential clinical holds

    Contact us »

    Client Spotlight Phase-Specific Regulatory Support for an Innovative Parkinson's Treatment

    Hear the leadership of Performance MedTech share their experience partnering with The FDA Group to prepare clinical trials for an exciting new Parkinson's treatment.

    Contact us »

    Let's bring your therapy to human trials and beyond.

    Contact us today to take your first step toward human clinical trials. A flawed IND submission can cause significant delays, potentially holding up your drug development process for months or even years. Our IND submission experts provide personalized support to maximize the likelihood of a successful, delay-free submission.

    We understand that every drug development program is unique. That's why we offer individualized support tailored to your specific needs. Our experts will work closely with you to:

    • Develop a comprehensive IND submission strategy
    • Identify and address potential regulatory hurdles
    • Optimize your preclinical data presentation
    • Craft compelling clinical protocols
    • Ensure all aspects of your submission meet FDA requirements

    Contact us »

    Frequently asked questions What are the types of INDs?

    There are two categories of Investigational New Drug applications (INDs):

    • Commercial INDs are for drugs intended for the open market, including those created by non-profit organizations with the aim of eventually commercializing the drug. The application process and timeline for a Commercial IND is more complex and lengthier compared to a Research IND.
    • Research INDs  are used to demonstrate the effectiveness of a new use for an already approved drug. These applications are submitted by physicians and involve a less complex process than Commercial INDs. For instance, Research INDs typically involve fewer investigators and are often conducted at a single testing site.

    Frequently asked questions How do we submit an IND application?

    You must ensure that your IND application is approved by the FDA before transporting your investigational drug/biological product across state lines to clinical sites. The process for submitting an IND can be complex and difficult to comprehend.

    For instance, Commercial IND applications must be submitted through the FDA’s Electronic Submissions Gateway, while Research IND applications can be submitted in paper form to the relevant address. This is just one example of the complexities within the IND application and submission process.

    Therefore, working with an experienced FDA consultant will help ensure that you are well-prepared and on the right track. The FDA Group will collaborate with you to ensure that your IND application meets the FDA’s stringent filing requirements and contains all the necessary components.

    Frequently asked questions What are the FDA's IND filing requirements?

    Each IND application should include the following:

    • Form FDA 1571 (IND application cover letter)
    • Form FDA 1572 (Investigator's statement)
    • Form FDA 3674
    • Table of contents
    • Introductory statement
    • General investigational plan
    • Investigator's brochure
    • Protocol(s): study protocol(s), investigator data, facilities data, IRB
    • CMC data, including environmental assessment or claim for the exclusion
    • Nonclinical: pharmacology and toxicology data
    • Clinical: previous human experience 
    • Additional information to support the IND filing

    We will thoroughly review the IND application together, and our staff will give you a finalized version that is FDA-ready. The IND application will become effective 30 days after the FDA receives it (unless it is subject to a clinical hold), or sooner if the agency notifies the sponsor that clinical trials can commence.

    Why work with The FDA Group?

     
    • Exclusive life science focus and expertise
    • Dedicated account management team
    • Right resource, first time (95% success)
    • 97% client satisfaction
    • Total Quality Guarantee

    Contact us »

    Contact us and get the conversation started Get expert guidance for your upcoming submission.

    The FDA Group will guide you through every step of the IND submission process and ensure your application is error-free to meet filing requirements and ensure a successful interaction with the FDA. To learn more about how we can help you develop a successful IND application for submission to the FDA, contact us today.

    Use the form below to tell us more about your IND consulting needs. We'll follow up within one business day.