CTD Dossier Templates for the US and EU Regulatory Authorities

Accelerate Your Path to Market with Zenovel’s expert regulatory solutions from IND to MAA

We assist you in seamless & streamlined process of regulatory submission by our comprehensive CTD dossier templates services.

Zenovel provides Customized Common Technical Document (CTD) dossier templates for regulatory submissions to US and EU agencies, simplifying the preparation and submission of pharmaceuticals and biologics documentation, as they meet unique standards set by the EMA and the US FDA.

Most regulatory applications must be submitted in ICH-harmonized CTD format, as per EU and US Health Authority regulations. Efficient management of submissions and lifecycles is achieved through a thorough submission methodology and standardized CTD dossier templates, all within reasonable time and financial constraints.

We offers customized CTD dossier templates for various regulatory applications, including INDs, IMPDs, MAAs, BLAs, NDAs, and ANDAs for pharmaceutical and biological goods, making them easier to understand and utilize.

We offer templates for the following application submissions

Investigational New Drug Application (IND) template

Our IND templates simplify the authoring and submission of Phase I, II, and III clinical trial applications to the US FDA. These templates provide detailed information on regulatory requirements for biological and pharmaceutical goods, allowing applicants to comply with FDA expectations. The metadata also provides in-depth information on potential clinical-hold problems related to Clinical Management Control (CMC) requirements and advice on handling CMC-related clinical-hold problems.

Biologic Dossier Template- Biologic Licensing Application (BLA)/ Marketing Authorization Application (MAA)/ New Drug Application

We have developed CTD templates for US and EU biologics marketing authorization dossier submissions. These templates are encrypted with specific metadata for each agency and application, providing guidance on regulatory requirements and potential issues like application-hold and refuse-to-file. The metadata also outlines standard specifications for biological products and production processes. The applicant can adhere to unique metadata for each application type and agency, and the same CTD data package can be updated or modified for the next country-submission.

Investigational Medicinal Product (IMP) Dossier Template

We has personalised templates simplify the creation and submission of an IMPD for clinical programmes to EU HAs and member states. These templates must satisfy pharmaceutical and biological product regulations, allowing applicants to adhere to metadata based on product type to meet HA needs and expectations.

New Drug Application (NDA)-505 (b)2 Template

Pharmaceutical product innovators can file for innovations in generic pharmaceuticals under the FDC Act by altering formulation, components, administration method, dosage schedule, and API using customised NDA 505(b) 2 templates. These templates provide regulatory references for most RTR concerns for all types of pharmaceutical products, including tablets, capsules, solutions, suspensions, injectable, and topical.

Abbreviated New Drug Application (ANDA) templates

Insufficient understanding of GDUFA II, RTR prerequisites, and ANDA readiness can lead to ANDA rejections, costing company’s time and money. To avoid this, company should submit an ANDA using the correct data presentation strategy, including in-depth details and regulatory references for various generic medicine dosage forms.

EU marketing Authorization (MAA) templates.

MAA CTD templates have been prepared for EU MAAs relating to pharmaceutical items, containing encrypted metadata outlining regulatory requirements for generic pharmaceutical goods in various formulation forms such as tablets, capsules, solutions, suspensions, and injectables, to be submitted via relevant processes.

Ensure your submission meets highest standards by our deep understanding of the regulatory process- US and EU authorities.

We customized CTD dossier templates to fit the specific needs of your pharmaceutical and biological products.

Our pre-formatted templates and checklists are easy to edit, allowing you to customize documents.

For product registration, each template is encrypted with specific metadata prepared by regulatory experts.

Reach out to us for any inquiries or support needs.

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CTD Dossier Templates for the US and EU Regulatory Authorities

We assist you in seamless & streamlined process of regulatory submission by our comprehensive CTD dossier templates services.

We offer templates for the following application submissions

Investigational New Drug Application (IND) template

Biologic Dossier Template- Biologic Licensing Application (BLA)/ Marketing Authorization Application (MAA)/ New Drug Application

Investigational Medicinal Product (IMP) Dossier Template

New Drug Application (NDA)-505 (b)2 Template

Abbreviated New Drug Application (ANDA) templates

EU marketing Authorization (MAA) templates.

Blogs and news

Our Latest Article

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Ensuring Data Integrity: Best Practices and Considerations

Enhancing Clinical Studies with GCP Audit and Monitoring

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