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

Freyr Expertise

Key features of Freyr CTD dossier 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 the 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 the formatting time during content authoring and accelerate the creation of harmonized documents.

• Portability: CTD dossier templates are configured considering the industry best practices for pharmaceutical/biological products’ lifecycle 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 the 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 (IND) applications to the US FDA for Phase I/Phase II/Phase III clinical studies (direct Phase II/III submissions if initial phase studies are waived off by the Agency). Metadata in the IND templates will provide information on the 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 templates facilitate authoring and submission of an Investigational Medicinal Product Dossier (IMPD) to the applicable EU Health Authorities/member states for intended clinical programs. Metadata in the IMPD templates meet the Regulatory requirements of both pharmaceutical and biological products. Based on the product type, applicants can follow the metadata to meet the 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. These standard set of templates are encrypted with agency-specific (US/EU) and application-specific (BLA/NDA/MAA) metadata that provide guidance on the biologics Regulatory requirements considering potential issues for Refuse-to-File (RTR) and application hold.

Metadata also details the typical requirements for different types of biological products (e.g. recombinant protein products) and for the manufacturing process 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 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 the 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 for the innovation done in generic products with respect to 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

Lack of thorough understanding on GDUFA II, 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 the appropriate data presentation approach with compliance to RTR issues 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 specially configured for submitting the EU marketing authorization applications for pharmaceutical products through the applicable submission procedure (CP, MRP, DCP, and NP). Metadata encrypted in the MAA templates provide Regulatory requirements for generic pharmaceutical products for varied formulation types (tablets, capsules, solutions, suspensions, injectables, etc.).