IND Preparation, Submission and Management
CERES Regulatory Services specializes in providing comprehensive Investigational New Drug (IND) preparation services, designed to navigate the intricate process of IND submission with precision and strategic foresight. Our approach is tailored to meet the unique needs of your product, ensuring alignment..
CERES Regulatory Services
IND Preparation, Submission and Management
CERES Regulatory Services specializes in providing comprehensive Investigational New Drug (IND) preparation services, designed to navigate the intricate process of IND submission with precision and strategic foresight. Our approach is tailored to meet the unique needs of your product, ensuring alignment with FDA requirements and optimizing the chances of successful IND acceptance. At CERES, we understand that a well-prepared IND is crucial for the seamless progression of your drug development program.
Key Components of Our IND Preparation Services
Our IND preparation services encompass several key components, each designed to streamline the submission process and enhance the likelihood of approval
Document Compilation
We meticulously compile all necessary documentation, ensuring completeness, accuracy, and compliance with FDA guidelines. This includes preclinical study reports, manufacturing information, and the proposed clinical protocol.
Regulatory Strategy Development
Our experts develop a tailored regulatory strategy that addresses the specific needs of your product, therapeutic area, and target patient population. This strategy is designed not only to meet current regulatory standards but also to anticipate future requirements and challenges.
Alignment with FDA Requirements
Ensuring your IND submission is perfectly aligned with FDA requirements is our top priority. We navigate the regulatory landscape with expertise, adjusting our strategies to comply with evolving guidelines and expectations.
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Strategic Approach to Regulatory Queries and Feedback
CERES Regulatory Services adopts a strategic approach to addressing regulatory queries and obtaining feedback. We proactively engage with regulatory authorities to refine the IND strategy before formal submission. Our goal is to anticipate potential questions and concerns, addressing them ahead of time to streamline the review process.
Pre-IND Meetings
We facilitate and prepare for pre-IND meetings with regulatory authorities, ensuring that all questions are thoroughly addressed and that feedback is incorporated into the IND submission. These meetings are a crucial step in aligning the IND strategy with FDA expectations and refining the submission for success.
eCTD Format Submission
Proficiency in compiling and submitting IND packages in the electronic Common Technical Document (eCTD) format is a hallmark of our service. Our team ensures that your submission is organized, navigable, and meets the technical standards required for electronic submissions, facilitating a smoother review process by the FDA.
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Making the Difference in IND Preparation and Submission
Choosing CERES Regulatory Services for your IND preparation and submission needs means partnering with a team that has the expertise, strategic insight, and commitment to make a significant difference in the success of your drug development program. Our comprehensive approach, from document compilation to strategic planning and regulatory alignment, is designed to optimize your chances of IND acceptance.
With CERES Regulatory Services, you gain more than just a service provider; you gain a strategic partner dedicated to navigating the complexities of IND submission. We ensure that every aspect of your submission is meticulously planned and executed, reflecting the unique value of your product and maximizing its potential for success. Let us guide you through the IND preparation and submission process, turning regulatory challenges into opportunities for advancement.
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Navigating the IND
An Investigational New Drug (IND) application is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial – in essence an IND is an application through which the applicant seeks permission to dose/test a new drug in humans for the first time, although legally it is a request for an exemption from a statutory requirement that prohibits interstate commerce. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
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A clinical study is required for an IND if it is intended to support a:
- New indication
- Change in the approved route of administration or dosage level
- Change in the approved patient population
- Significant change in the promotion of an approved drug
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The main elements of an IND are
- Animal Pharmacology and Toxicology Studie: Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
- Chemistry and Manufacturing Information (CMC): Information on the chemical composition, manufacturing methods, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent and active batches of the drug.
- Clinical Protocols and Investigator Information: Detailed protocols for proposed clinical studies, details on the clinical investigators, commitments to obtain informed consent from the study subjects, confirmation that a review of the study will be done by an institutional review board (IRB).
- Investigators Brochure (IB): An IND must also include an Investigator’s Brochure which is a document intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients who will be enrolled.
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