DDReg offers Comprehensive eCTD Publishing and Submission Services.
While some regions accept paper dossier submissions, the eCTD format has been declared mandatory by many regulatory authorities worldwide. Thus, the need to convert paper INDs, NDAs and DMFs to the eCTD format is imperative. Marketing authorization applications must be technically compliant with respect to submitted documents. To ensure appropriate assessment of the regulatory procedures, the baseline sequence must be submitted. This should include the compiled dossier in the eCTD or as a NeeS. Technical assessment of the eCTD against ICH specifications is a requirement to ensure validation before it can be submitted.
DDReg ensures appropriate conversion of dossiers, while adhering to guidelines and specifications. DDReg uses fully validated eCTD tools that are 21CFR part 11 compliant.
DDReg’s publishing services include:
Legacy dossier conversion to CTD as NeeS or as eCTD
Publishing initial applications, query responses, variations, aggregate reports using eCTD tool
eCTD submission through agency web portal or gateway
Maintaining product specific filing sequence for initial submission & response to queries
eCTD v 4.0 support
Basics of eCTD Publishing and Submission Services
eCTD publishing is the creation, compilation, and submission of regulatory documents in a structured electronic format. It plays a pivotal role in streamlining the regulatory submission process for pharmaceutical companies that are looking to obtain approval for their products. The standardized eCTD format allows for efficient information exchange between industry stakeholders and regulatory agencies across the globe. eCTD publishing replaces the traditional paper-based submissions which provides increase efficiency and consistent with respect to the regulatory services review process.
In eCTD submissions, regulatory documents are organized into predefined structure, constituting modules that address different aspects of the drug development process. The modular approach, commonly referred to as the “granularity” of the submissions, enhances the accessibility and traceability of information. Global regulatory agencies encourage eCTD use for its ability in improving data quality, reducing errors, and expediting regulatory review processes.
Indeed, efficient eCTD publishing ensures that regulatory submissions adhere to the required regulatory standards with an emphasis on accuracy and completeness. Submission process involves compiling documents in a format that meets the ICH guidelines, to ensure global acceptance of the submissions. In the realm of regulatory affairs, eCTD publishing and eCTD submissions reflect a commitment by stakeholders to modernization and aligns with the industry’s proactivity in shifting towards digital transformation. Pharmaceutical organizations that incorporate eCTD benefit from challenges related to administrative burden, timely regulatory reviews, and overall enhanced communications with global authorities. The use of eCTD is now a “best practice” and demonstrates compliance with regulatory requirements and fostering a collaborative & harmonized approach between industry and regulators.
eCTD publishing and eCTD submissions are crucial components of regulatory affairs, that offer a standardized and efficient method for preparing and submitting regulatory documents for pharmaceutical market approval. The eCTD approach inevitably enhances regulatory processes and reflects the industry’s commitment to embracing technological advancements for the benefit of patient health and safety.