eCTD Publishing and Submission :
The electronic Common Technical Document (eCTD) is a standardized electronic format and process used by pharmaceutical companies for submission of dossier for Intermediate, Active Pharmaceutical ingredients (API), Excipients, Packaging Material and Finished Dosage Form (FDF) to various global health authorities such as the USFDA, EMA, MHRA, HEALTH CANDA, GCC, SWISS, TGA, TFDA, JFDA, SAHPRA, ECOWAS etc.
Masuu specializes in comprehensive regulatory operation services, particularly in eCTD Publishing and Submission, catering to a diverse range of sectors including Pharmaceuticals, Biopharmaceuticals, Healthcare, CMOs, and Clinical Research. Our expertise extends to both regulated and semi-regulated markets, ensuring seamless submission processes in electronic formats such as eCTD, Nees, VneeS, and pCTD.
Backed by a highly qualified team of regulatory operations professionals, Masuu brings extensive experience in various facets of regulatory operations. Our services encompass submission management and planning, strategic publishing, document level publishing (DLP), submission level publishing (SLP), dispatching submissions to regulatory authorities, archival procedures, and troubleshooting.
Masuu’s Regulatory Operations team possesses specialized proficiency in electronic submissions, particularly in eCTD and Nees formats. We excel in managing pre-approval activities, including original applications and amendments, as well as post-approval tasks such as variations/supplements, annual reports, and PSUR/PADER submissions to Global Health Authorities.
Our Services
Inclusive End-to-End Regulatory Operations (eCTD Publishing) Services Support for Global Regulatory Submissions Management.
Our Expertise
Empowering Regulatory Success Through Comprehensive Support & Consultation
We excel in regulatory operations (eCTD Publishing and Submission), offering streamlined publishing and submissions management services. Our expertise in document, report and submission level publishing and legacy conversions (Paper to eCTD conversion) ensures error-free submissions and compliance with global standards.
Comprehensive Regulatory Solutions for Seamless Operations
We provide complete eCTD Publishing support, covering all aspects of regulatory operations, from publishing planning to submissions dispatch and archival. With our expertise, we ensure smooth and efficient operations throughout the submission lifecycle.
Ensuring Accuracy and Compliance in Regulatory Submissions
Our regulatory operations 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.
Harnessing Technology for Effective Regulatory Operations
We utilise cutting-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.
Type for Format
- eCTD
US, Europe, UK, Canada, Australia, South Africa, GCC (Oman, Qatar, Bahrain, Kuwait, UAE and Saudi Arabia), Switzerland, ECOWAS, Thailand and Jordan - NeeS
Australia, New Zealand, Bosnia and Herzegovina - pCTD
Emerging market like LATAM, MENA, APAC, ASEAN, and CIS region - vNeeS
European region and GCC