eCTD Publishing & Submission

  1. Home / eCTD Publishing & 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.

Streamlining Global Electronic Submissions

Submission Management

Component, Document and Report Level Publishing

Submission Level Publishing

Submission eValidation and Verification

Submission Dispatch and Archival

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.

End-To-End eCTD Publishing and Submission Support

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.

Error-free Submissions and Compliance

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.

Advanced eCTD Publishing and Submissions Tools

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

What Our Client’s Say About Us

Masuu Global is a team of experts with ample knowledge in process of pharmaceutical industry, they are the perfect partners for our organisation. We have been doing business with Masuu Global since their inception 2018. Every time we have seen that they come up with new initiatives to ease the process of our submissions.

Chief Scientific OfficerBioPharma – USA

Masuu expertise in delivering the right solutions is prominent to us. The team of Masuu are experts in various US Agent services, GMP Audit, eCTD submissions to different health authorities & their softwares which helped us in achieving our company goals.

Head QualityPharma API – India

We appreciate the service excellence, all the regulatory services like ANDA, NDA, eCTD and Labeling are supported & completed by Masuu Global and its entities. Their services and software are amazing, not only they have secured crucial project clearance before the expected timelines, but their challenging commitments are something exceptional.

Head R&DUSA

We’re fortunate to have a vendor like Masuu Global. Their services & products are foremost best in the industry, overwhelming support with know-how things works to achieve the business acumen by following the agency standards makes them prominent expert for all our requirements.

Vice President TechnicalPharma API – USA

Initially, we have chosen Masuu Global for one of our crucial submission project. Not only the project was successfully completed within the derived timeline, their professionalism, expertise, guidance and support is really overwhelming. Since then we have been using Masuu Global services & eCTD Global softwares for all our submissions with USFDA.

Sr. ManagerFDF Manufacturing – India

Masuu Global are one of the finest consultants I’ve worked with. Their Quality, Expertise, Commitment & Deliverables is what make them stand out. The management & team are highly knowledgeable, perfectly skilled to complete the challenging tasks for us. I enjoy working with them, will be working with them, will recommend to anyone for regulatory & quality consulting.

Sr. Manager Regulatory AffairsCMO – India

It’s been more than 3+ years we have been doing business with Masuu Global, their initiatives are the fablous in the industry. Not only their deliverables are finest, they do have outstanding products which made our eCTD & SPL project accomplishments at ease. Masuu is a philanthropic organisation as well which gives away the profits towards the children’s education who are backward & needy.

DirectorAPI Manufacturer – India
Book a Demo