Our Comprehensive eCTD Solutions
At Clinreg Partner, we provide expert eCTD publishing services, handling INDs, NDAs, DMFs, and BLAs with precision. Our team ensures seamless, compliant submissions tailored to your needs.
eCTD Preparation
Properly structure, format, and hyperlink documents to ensure regulatory compliance and seamless submission.
Submission Management
Handling IND, NDA, ANDA, BLA, and eDMF submissions, including amendments and lifecycle maintenance.
Project Management
Coordinate regulatory submissions from start to finish, ensuring efficiency, accuracy, and full compliance.
FDA Gateway Submission
Transmit regulatory submissions securely via FDA-compliant gateway with 21 CFR Part 11 encryption.
Electronic Common Technical Document (eCTD) Services
Navigating the complexities of electronic Common Technical Document (eCTD) submissions can be daunting. At ClinReg Partners, we specialize in streamlining this process, ensuring your regulatory submissions meet global standards with precision and efficiency.
Meet Bani Tchekanova, MS, PhD,
Dr. Bani TchekanovaVice President & Chief Principal Advisor, Regulatory Affairs | ClinRegPartners
Dr. Bani Tchekanova is an internationally recognized expert in global regulatory affairs with over 20 years of experience leading successful drug development and registration strategies across the U.S., EU, and Asia.
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As Vice President and Chief Principal Advisor at ClinRegPartners, she guides pharmaceutical and biotech companies through every stage of clinical development, regulatory submissions, and global health authority interactions.
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Dr. Tchekanova specializes in complex regulatory pathways, including 505(b)(2), breakthrough therapy designation, orphan drug applications, and drug-device combination products. Her leadership spans therapeutic areas such as immunology, oncology, ophthalmology, and rare diseases.
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A visionary in regulatory innovation, Dr. Tchekanova is also at the forefront of integrating artificial intelligence into regulatory strategy and operations. She is actively developing AI-driven frameworks to optimize submission planning, safety surveillance, and evidence generation.
Dr. Tchekanova is a trusted advisor to startups and multinational firms alike, and frequently delivers training, webinars, and thought leadership on regulatory trends, FDA expectations, and AI applications in drug development.
How it Works
We simplify eCTD submissions with expert guidance, ensuring compliance, accuracy, and a seamless process.
1. Assembling the Submission Package
A successful eCTD submission begins with gathering all the necessary documents from across various departments, including regulatory affairs, clinical trials, and manufacturing. These documents should be carefully reviewed to ensure they meet all regulatory standards and are formatted properly.
2. Validation and Quality Control
Before submission, the package must undergo rigorous quality assurance and validation checks. Use specialized software tools to perform technical validation, ensuring that all files comply with eCTD standards.
3. Engaging with the FDA and Other Regulatory Authorities
Early and proactive engagement with regulatory bodies like the FDA is essential. Be prepared to respond to questions or requests for additional information. This interaction may occur through pre-submission meetings or during the review process.
4. Utilizing the FDA Gateway
The FDA provides an electronic submission gateway (ESG) for submitting eCTD packages. Understanding how to use the ESG efficiently is critical to ensure timely and secure submissions. Pharma executives should ensure their teams are familiar with the system.
Take the First Step and Get Started
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