Publishing & Submissions
The International level of Regulatory Compliance is constantly changing, so we need to adapt to all future changes. For life science companies Publishing and Submission plays a challenging role as documents are the only language the world believes. The company should know ‘WHEN’ to go to regulatory Publishing and submission for entering into competitive market of drugs. Another vital factor is that company should have the best of knowledge about the prospects of regulatory compliance and its effect on their business. Tammina Life science assures your company with all the required knowledge and with the best of output for your company.
Tammina Life science innovative process provides flexibility while managing difficult projects that often differ from well-considered plans and requires intelligent adjustments as your company marches to completion. Tammina Life science has a team of competing priorities. Tammina Life science experts have a good understanding and training in terms like Electronic Common Technical Document (eCTD) and work like converting papers to eCTD. Tammina Life science believes in accuracy, efficiency and automating the regulatory process. Tammina Life science helps your company by filing multiple submissions in a short period of time. Our company delivers high-quality submissions within the limited time.
Tammina Life science has three client-based team – Submission Owner, Submission coordinator and Publishing Lead. The Regulatory Submission Owner (RSO) delivers and administers the project status. The RSO manages all the publishers involved and checks through resource allocation. The RSO tracks and updates the eCTD submissions and status at the file level. RSO looks through the project risks and tracks it. He is a technical contractor to Food and Drug Administrator (FDA) and even obtains application number for FDA. The submission Coordinator completes all compilation and quality assurance of your products. He improves submission quality by marking all regulatory complaints into PDF. This also helps in reducing the number of processes. The publishing lead helps to submit the submissions on time.
Why Tammina Life science :
- We help your company to overcome the challenges lead cause of submissions.
- We help in service delivery, reduce operation cost, improve performance and accelerate towards the global market.
- Our Company helps you with preparing submission component by scanning services, document and report publishing, by structuring the product labels.
- Tammina Life science experts do eCTD and Non-eCTD submission planning and tracking.
- Tammina Life science has well-trained experts in secure electronic submission, submission and publishing lifecycle process, and in studying reports for the paper.
- Tammina Life science has a periodic quality check for time management.
- Tammina Life science experts maintain the clinical protocols.
- We submit a variant to an existing application.
- Our experts get updated and trained to instant changes in the regulatory process.
- Tammina Life science experts continuously monitor projects.
- Our experts go through step by step maintaining the life cycle process of submission and publishing.
- Our Regulatory experts have a great understanding of IT and technical guidelines which will help for eCTD.
- Tammina Life science supports NeeS submission formats too.
- Tammina Life science empower your company to effectively meet all their specific submission requirements for proper and faster approval of drugs, medical devices, and biologics by Global HAs.