Efficient coordination & comprehensive regulatory operation services for pharmaceutical applications worldwide.
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.
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.
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.
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.
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.
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.
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.
Our meticulous approach to component level publishing ensures precise assembly and formatting of individual regulatory components, creating a cohesive and compliant regulatory submission package.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Optimize your regulatory operations with Masuu. Experience seamless compliance and efficiency. Get in touch now!Contact Us
