CTD Dossier Templates for the US and the EU Regulatory Submissions

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CTD Dossier Templates for the US and the EU Regulatory Submissions – Overview

The U.S. and EU Health Authorities (HAs) have mandated receiving most Regulatory applications in ICH-harmonized CTD format. In this scenario, a thorough submission approach and the use of standardized CTD dossier templates enable effective management of Regulatory submissions and subsequent lifecycle management within less time and cost-effective parameters.

Freyr offers customized CTD dossier templates for various Regulatory applications like INDs, IMPDs, MAAs, BLAs, NDAs, and ANDAs for pharmaceutical and biological products.

Freyr Expertise and Advantages

Dossier Templates for the US and the EU Regulatory Submissions - Freyr Expertise

Key features of Freyr’s CTD dossier templates are as follows:

• Metadata: The dossier templates (CTD) for each application type are encrypted with specific metadata that guide the authors in understanding the HA’s expectations for the application and for drafting the content for each section in the application. This metadata has been prepared by Regulatory experts using their real-time experience of multiple pharmaceutical/biological products’ submissions to various HAs. Metadata also provides references to applicable regulations/guidance documents and the best practices to be followed for product registrations with the applicable authorities (US FDA and EU EMA).

• User-friendly Features/Options: Freyr’s dossier templates are pre-loaded with the required formatting, CTD document granularity, and standardized format elements such as headers, titles, tables, figures, and auto-numbering of tables and figures for consistency of data presentation. Customized toolbars and styles reduce the formatting time during content authoring and accelerate the creation of harmonized documents.

• Portability: CTD dossier templates are configured considering industry best practices for pharmaceutical/biological products’ lifecycle management and support reuse of content for multiple applications with minimal re-work/re-drafting efforts.

• User guide: An easy-to-understand “User Guide” is provided with the templates’ package that helps the author to utilize the features to the maximum extent while drafting the CTD sections. 

  • Investigational New Drug (IND) Application Templates

Freyr’s customized IND templates facilitate the authoring and submission of IND applications to the US FDA for Phase I/Phase II/Phase III clinical studies (or only Phase II/III submissions if the initial phase studies are waived off by the Agency). Metadata in the IND templates provides information on the Regulatory requirements for pharmaceutical and biological products. Based on the product type, applicants can follow the metadata instructions to meet the US FDA expectations/requirements. Metadata also provides thorough insights on potential clinical-hold issues about CMC requirements, with the best way to manage CMC-related clinical-hold issues.

  • Investigational Medicinal Product (IMP) Dossier Templates

Freyr’s customized templates facilitate the authoring and submission of an IMPD to the applicable EU HAs/member states for intended clinical programs. Metadata in the IMPD templates must meet the Regulatory requirements of pharmaceutical and biological products. Based on the product type, applicants can follow the metadata to meet the HAs’ expectations/requirements.

  • Biologics Dossier Templates - Biological License Application (BLA)/Marketing Authorization Application (MAA)/New Drug Application (NDA)

Freyr has developed CTD templates for biologics marketing authorization dossier submission for the US and the EU. These standard sets of templates are encrypted with Agency-specific (US/EU) and application-specific (BLA/NDA/MAA) metadata that provides guidance on the biologics Regulatory requirements, considering potential issues like Refuse-to-File (RTR) and application-hold.

Metadata also details the typical requirements for different biological products (e.g., recombinant protein products) and the manufacturing technologies involved (e.g., cell culture, fermentation, and downstream processing).

While authoring the dossier, the applicant can follow the metadata specific to the intended application type (BLA/MAA/NDA) and Agency (US/EU). Subsequently, the same CTD data package can be updated/modified for the next country-submission by following the metadata requirements specific to the second country (e.g., US CTD to EU or vice versa, or from one EU country to the other).

  • New Drug Application NDA - 505(b)2 Templates (Pharmaceuticals)

Specially customized NDA 505(b)2 templates for pharmaceutical products help applicants file for innovations in generic products for change in formulation, components, route of administration, dosing regimen, and/or API of the FDC Act. Metadata in the NDA templates provide Regulatory references to address most of the RTR issues for all types of pharmaceutical products (i.e., tablets, capsules, solutions, suspensions, injectables, topicals, etc.).

  • Abbreviated New Drug Application (ANDA) Templates

A lack of thorough understanding of GDUFA II, RTR requirements, and ANDA preparation may lead to the rejection of ANDAs, which leads to a loss of revenue and valuable time. Hence, it is essential to follow the appropriate data presentation approach during an ANDA submission. Freyr’s ANDA templates include detailed information and Regulatory references to address the RTR issues for different dosage forms of generic drugs (tablets, capsules, solutions, suspensions, injectables, topicals, etc.).

  • EU Marketing Authorization Application (MAA) Templates for Pharmaceuticals

MAA CTD templates are configured for submitting the EU MAAs for pharmaceutical products through the applicable submission procedures (CP, MRP, DCP, and NP). Metadata encrypted in the MAA templates provides Regulatory requirements for generic pharmaceutical products for varied formulation types (tablets, capsules, solutions, suspensions, injectables, etc.).