Dossier Templates for the U.S. and the EU Regulatory Submissions

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Overview

Overview

In the current Regulatory era,  U.S. and the EU health authorities have mandated receiving most of the Regulatory Applications in ICH harmonized CTD format. In this scenario, thorough submission approach and use of standardized CTD dossier templates enable effective management of Regulatory submissions, subsequent life cycle management within less time and cost-effective parameters.

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

Freyr Expertise and Advantages

Freyr Expertise

Key features of Freyr CTD templates:

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

• User-friendly Features/Options: Freyr’s dossier templates are pre-loaded with 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 toolbar and styles reduce formatting time during content authoring and accelerates the creation of harmonized documents.

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

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

  • Investigational New Drug (IND) Application Templates

Freyr’s customized IND templates facilitate authoring and submission of Investigational New Drug applications to the US FDA for Phase I/Phase II/Phase III clinical studies (direct Phase II/III submissions, in case if initial phase studies are waived off by the agency). Metadata in the IND templates will provide information on Regulatory requirements for both 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 pertaining to CMC requirements along with the best possible way out to manage the CMC related clinical hold issues.

  • Investigational Medicinal Product (IMPD) Dossier Templates

Freyr’s customized IMPD templates facilitate authoring and submission of Investigational Medicinal Product Dossier to applicable EU health Authorities/Member states for intended clinical programs. Metadata in the IMPD templates meet Regulatory requirements of both pharmaceutical and biological products. Based on the product type, applicants can follow the metadata to meet Health Authorities 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. This standard set of templates are encrypted with the agency-specific (US/EU) and application-specific (BLA/NDA/MAA) metadata that provides guidance on Biologics Regulatory requirements considering potential issues for refuse to file and application hold.

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

While authoring the dossier, the applicant can follow metadata specific to the intended application type (BLA/MAA/NDA) and agency (US/EU). Subsequently same CTD data package can be updated/modified for next country submission by following the requirements mentioned in the metadata specific to the second country.

(E.g. US CTD to EU or vice versa or from one EU country to other EU countries).

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

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

  • Abbreviated New Drug Application (ANDA) Templates

Lack of thorough understanding on GDUFA II, Refuse to Receive (RTR) requirements and ANDA preparation may lead to rejection of ANDAs which leads to loss of revenue and valuable time. Hence, it is essential to follow appropriate data presentation approach with compliance to RTR issues during ANDA submission. Freyr’s ANDA templates include detailed information and Regulatory references to address the Refuse to Receive (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 specially configured for submitting the EU marketing authorization applications for pharmaceutical products through applicable submission procedure (CP, MRP, DCP and NP). Metadata encrypted in the MAA templates provide Regulatory requirements for generic pharmaceutical products for formulation types (tablets, capsules, solutions, suspensions, injectables, etc.).