Successfully Enabled CTD Modules Preparation within Stringent Timelines

Submission of Common Technical Document Modules: Case Study Overview

A well-established pharmaceutical company needed support in preparing Common Technical Document (CTD) Modules within aggressive internal timelines for submission. Our team of skilled medical writers and formatters delivered submission-ready quality documents, ensuring a timely submission of the Common Technical Document Modules.

Read more about how our experts assisted the client in successfully meeting their CTD submission deadlines.

Enabling CTD Modules Preparation: Case Study Highlights

• The Common Technical Document is an internationally agreed format accepted by Europe, USA and Japan regulatory authorities and is organised into five modules (CTD Modules 1 -5).
• The pharmaceutical company partnered with APCER for the preparation of CTD modules for Marketing Authorization Application (MAA) submission of their innovative product in the European Union (EU).
• APCER delivered a well-written and compliant CTD dossier within the client’s strict timelines for the EU MAA submission.
• The dossier adhered to all relevant EU regulatory guidance, ensuring a smooth submission process.
• The client provided excellent feedback, highlighting the superior quality of the modules

APCER’s Medical Writing Capabilities

Experienced Team of Medical Writers

Our team of experienced and specialized medical writers bring rich experience across various therapeutic areas and possess expert knowledge in preparing regulatory documents, including the Common Technical Document as well as other scientific communications.

Robust Review

We implement a robust two-step review process to ensure 100% quality control for all Common Technical Document Modules.

High-quality Deliverables

Delivering high-quality results consistently, our team exceeds expectations in the preparation of the CTD. Our commitment to excellence ensures that all Common Technical Document Modules are submission-ready and tailored to meet specific regulatory requirements.

Copyediting Support:

A dedicated team of copyeditors and typesetters performs thorough checks on language, grammar, and style, ensuring that each Common Technical Document Module is polished and e-submission ready. This attention to detail helps streamline the regulatory submission process and enhances the overall quality of the documents.

Customized Solutions:

Our expertise in the Common Technical Document Modules ensures that your submissions are not only accurate and comprehensive but also adaptable to new regulatory guidelines.

Discover how our specialized team and tailored approach can support your medical writing needs.