Streamlining Global Pharma Submissions

Efficient coordination & comprehensive regulatory operation services for pharmaceutical applications worldwide.

Our Expertise

Empowering Success Through Comprehensive Support & Consultation

We excel in regulatory operations, offering streamlined publishing and submissions management services. Our expertise in document and report level publishing, structured product labeling, and legacy conversions ensures error-free submissions, compliance with global standards, and efficient data analysis.

End-to-End Regulatory Support

Comprehensive Regulatory Solutions for Seamless Operations

We provide complete regulatory support, covering all aspects of regulatory operations, from planning to submissions. With our expertise, we ensure smooth and efficient operations throughout the regulatory 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 compliance risks and ensuring high-quality submissions.

Advanced Publishing and Submissions Tools

Harnessing Technology for Effective Regulatory Operations

We utilizes cutting-edge publishing and submissions tools, including NextGen eCTD Software, for efficient management of regulatory documents. Our advanced technology streamlines processes and facilitates quick reviews and approvals.

Expertise in Structured Product Labeling

Precision and Compliance in Product Labeling

Masuu Global specializes in structured product labeling, ensuring accurate and compliant labeling for pharmaceutical products. We adhere to FDA and Health Canada standards, facilitating electronic submissions and efficient labeling processes.

Legacy Conversions and Data Analysis

Seamless Transition and Data Analysis for Legacy Studies

Masuu Global facilitates smooth legacy conversions and offers expertise in data analysis for clinical and non-clinical research. We ensure compliance with FDA standards and leverage CDISC data models for effective legacy conversions and analysis.

Our Services

Comprehensive Regulatory Operation Services

Publishing & Submission

We offer end-to-end services, including dossier development, submission planning, tracking, publishing, and final submissions to Health Authorities. With expertise in various formats like paper, electronic, eCTD, and NeeS, they ensure error-free and on-time submissions.

Component Level Publishing

Our meticulous approach to component level publishing ensures precise assembly and formatting of individual regulatory components, creating a cohesive and compliant regulatory submission package.

Document Level Publishing

With attention to detail, we manage document level publishing, ensuring proper formatting, pagination, and adherence to regulatory guidelines. Our streamlined processes guarantee efficient document compilation and submission.

Report Level Publishing

Our experienced team handles report level publishing, ensuring accurate placement of tables, graphs, and figures, along with precise formatting and pagination. We guarantee compliance with regulatory requirements for seamless report submission.

Submission Level Publishing

We excel in submission level publishing, organizing and formatting regulatory submissions to meet industry standards. Our expertise ensures complete and compliant submission packages, enhancing your regulatory success.

eCTD Lifecycle Management

Our comprehensive eCTD lifecycle management services cover dossier creation, maintenance, and updates throughout the product lifecycle. We handle technical validation, document publishing, and lifecycle tracking, ensuring compliance with evolving regulatory requirements.

Submission Dispatch

Our efficient submission dispatch services ensure timely delivery of regulatory submissions to health authorities worldwide. We handle the entire process, from preparing the submission package to coordinating with courier services, ensuring secure and prompt dispatch.

Archival Support

We provide reliable archival support for regulatory documents, ensuring secure storage, easy retrieval, and long-term preservation. Our robust systems and processes guarantee the integrity and accessibility of archived data, meeting regulatory requirements.

What Our
Client's Say
About Us.

Optimize your regulatory operations with Masuu. Experience seamless compliance and efficiency. Get in touch now!
Contact Us