Submissions & Publishing
Our Submissions and Publishing services in regulatory affairs involve managing the preparation, compilation, submission, and publication of regulatory documents required for the approval and commercialization of pharmaceutical products.
Key aspects and benefits of
Submissions and Publishing Services in Pharma
We provide complete eCTD Publishing support, covering all aspects of regulatory operaƟons, from
publishing planning to submissions dispatch and archival. With our experƟse, we ensure smooth and
efficient operaƟons throughout the submission lifecycle.
Our regulatory operaƟons team ensures error-free submissions, adhering to global regulatory standards.
We meticulously review and validate documents, minimizing eCTD related queries and ensuring high-
quality submissions.
We utilise cuƫng-edge publishing and submissions tools, including in-house eCTD Publishing and
submission management NextGen eCTD Software and NextGen PDF Plugin for efficient processing of
regulatory submission documents. Our advanced technology streamlines processes and facilitates quick
reviews by Regulatory teams.
Assist pharmaceutical companies in preparing and formatting regulatory documents according to the specific requirements of regulatory agencies such as the FDA, EMA, PMDA, and others. This includes Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and variations.
Submissions and Publishing services help compile and organize regulatory documents into submission-ready formats, ensuring completeness, accuracy, and consistency. We also provide document management systems or software platforms to facilitate version control, document tracking, and collaboration among stakeholders.
We offer strategic guidance and support for planning regulatory submissions, including timeline development, regulatory strategy formulation, and risk assessment.
With the increasing adoption of electronic submission formats such as eCTD (electronic Common Technical Document) and NeeS (Non-eCTD electronic Submissions), Submissions and Publishing services. Pharmazone specializes in Preparing, Validating, and Submitting electronic regulatory dossiers in compliance with regulatory standards and technical requirements.
Submissions and Publishing services facilitate interactions with regulatory authorities by coordinating meetings, preparing briefing documents, and responding to regulatory queries during the review process.
Beyond initial submissions, by these services support lifecycle management activities by managing post-approval submissions, variations, renewals, and updates to regulatory dossiers throughout the product lifecycle.
Pharmazone’s Submissions and publishing services also assist in the publication of regulatory documents in scientific journals, regulatory databases, and public repositories. This involve formatting manuscripts, ensuring compliance with journal guidelines, and managing the submission and review process.
Our submissions and publishing services adhere to stringent quality assurance processes to ensure the accuracy, integrity, and compliance of regulatory documents with regulatory requirements and industry standards. This includes thorough document review, verification of data accuracy, and adherence to submission timelines.