IND Publishing and Submission Service

IND Workflow

Featured Services IND Application Writing eCTD CreationRegulatory Affairs Consulting Clinical Trial Data ManagementBiostatistical Analysis Post-Submission Support

Highlights FAQs Related Sections

With extensive experience of our regulatory team, Creative Biolabs provides pre-IND meeting, IND publishing, and submission to help gain IND approval to facilitate clinical trials of your drug candidate. We are committed to providing efficient, professional and cost-effective IND publishing and submission services to help our clients achieve their goals.

IND Submission Process

The IND submission process is complex and involves multiple stages. Creative Biolabs provides end-to-end support throughout the entire process:

Pre-IND Preparation

We assist you in completing preclinical studies, data organization, and analysis to lay a solid foundation for your IND application.

IND Application Writing

Our expert team will draft a high-quality IND application based on FDA requirements, including a summary, clinical trial protocol, and pharmaceutical information.

FDA Review

We closely monitor the FDA review process and maintain open communication to ensure a smooth application progression.

IND Approval and Clinical Trial Initiation

Upon IND approval, we will assist you in initiating clinical trials.

Our IND Services

Creative Biolabs offers a complete range of regulatory services for the entire IND submission lifecycle from IND application to post approval. We use an integrated science-intelligent regulatory technology to guide you through the drug development maze. With our entire service offering, we coordinate all your IND processes to ensure compliance and speed up your clinical trial route. Our experts are well-versed in a multitude of technologies and methodologies to help convert your novel therapeutic candidates into IND-filing success.

IND Application Writing

Consolidate your animal and in vitro data into a compelling preclinical study report.
Develop a scientifically sound clinical trial protocol tailored to your drug's characteristics and clinical objectives, including inclusion/exclusion criteria, dosing, and endpoints.
Provide detailed descriptions of the drug's chemical, physical, and manufacturing properties, as well as stability data.
By preparing three FDA forms under FDA regulations thoroughly, we can increase your chances of successfully obtaining IND approval.

Form 1571	The core application, providing clinical protocols, chemistry, manufacturing, and controls (CMC) data, and preclinical study results about the drug and study.
Form 1572	Focuses on the investigators and the ethics of the study, ensuring determination from an Institutional Review Board (IRB).
Form 3674	Ensures compliance with GCP guidelines throughout the trial.

eCTD Creation

The eCTD is structured into five modules that collectively provide a comprehensive overview of a drug product for regulatory submission. We can help you with:

Convert your data into the XML format specified by eCTD.
Build a complete electronic document following the five modules of eCTD.
Conduct thorough validation using specialized tools to ensure compliance with FDA requirements and submit the eCTD electronically to the FDA.

Fig.1 Five Modules Forming the eCTD Submission Process. (Creative Biolabs Original) Fig.1 Five Modules of the eCTD Submission.

Regulatory Affairs Consulting

Maintain close communication with the FDA to address any issues that may arise during the review process.
Stay abreast of the latest FDA regulations to ensure your application remains compliant.
Assist you in preparing and submitting responses to FDA inquiries.

Clinical Trial Data Management

Design and implement a data collection system to ensure data integrity and accuracy.
Input clinical trial data into an electronic data capture (EDC) system.
Conduct data cleaning and statistical analysis, and generate clinical trial reports.

Biostatistical Analysis

Develop a statistical analysis plan aligned with the clinical trial design.
Analyze clinical trial data using statistical software such as SAS and R.
Prepare statistical analysis reports to support clinical trial conclusions.

Post-Submission Support

Agency Communication Management

Development of responses to Information Requests within designated timeframes
Coordination of technical meetings with regulatory authorities
Implementation of agency-requested amendments
Management of submission lifecycle updates

Ongoing Compliance Monitoring

Regular assessment of regulatory requirement changes
Implementation of policy updates affecting current submissions
Continuous risk evaluation and mitigation strategies
Quality system maintenance and enhancement

Discuss Your Project →

Why Choose Creative Biolabs?

Deep Expertise in Immuno-Oncology: We have extensive experience in the immuno-oncology field and are well-versed in relevant regulations and guidelines.
Customized Solutions: We provide tailored solutions to meet your specific needs.
Proven Track Record: We have successfully assisted numerous clients in completing IND submissions and obtaining FDA approval.
Global Reach: Our global network enables us to provide comprehensive support.

With an expert regulatory publishing and submission team, Creative Biolabs caters value-added support for dossier package submission both in paper as well as CTD formats. We decode region specific technicalities to streamline submissions. Please contact us for more information and a detailed quote.

FAQs

What is the typical timeline for completing an IND submission process with your service, and what factors might affect this timeline?

Our standard IND submission process typically requires 8-12 weeks from initial documentation to final submission. This timeline can vary based on several factors: the complexity of your drug candidate, the completeness of existing documentation, and the therapeutic area. For instance, a novel biological product might require additional time for CMC documentation compared to a small molecule drug. We create a detailed project timeline during our initial consultation, incorporating buffer periods for potential agency questions and document revisions. For expedited programs, we can compress this timeline to 6-8 weeks through our accelerated service pathway.

What sets your IND publishing and submission services apart from other CROs in terms of success rate and quality assurance?

Our distinctive advantage lies in our comprehensive quality control system and experienced regulatory team. We maintain a 95% first-time approval rate through our proprietary three-tier review process: technical accuracy verification, regulatory compliance assessment, and submission readiness evaluation. Each submission undergoes review by at least two PhD-level regulatory experts with specific therapeutic area expertise. Our team includes former FDA reviewers who provide invaluable insights into agency expectations. Furthermore, we utilize advanced regulatory intelligence tools to stay current with evolving FDA guidelines and requirements.

What level of involvement is required from our team during the IND submission process, and how do you manage communication?

While we handle the technical aspects of submission preparation, we maintain a collaborative approach with your team. Typically, we require regular input during key milestones: initial strategy development, document review phases, and response to agency questions. We assign a dedicated project manager who serves as your single point of contact, coordinating weekly progress meetings and providing detailed status reports. Our communication platform includes secure document sharing, real-time project tracking, and 24/7 access to senior regulatory experts for urgent matters.

What is your approach to handling electronic submissions, particularly regarding technical requirements and validation?

Our electronic submission process utilizes validated eCTD publishing tools and automated quality control systems. We maintain current specifications for all major regulatory agencies and perform comprehensive technical validation before submission. Our process includes automated checks for hyperlink functionality, bookmark accuracy, and PDF compliance. We utilize a staged validation approach, testing both content and technical elements separately. Our publishing team maintains current certification on multiple eCTD platforms and regularly updates our systems to accommodate new technical specifications from regulatory agencies.