Regulatory environment is accelerating nowadays. In this process, labeling service has become really crucial and is the difficult business for the life science companies. The increasing needs of local label alignment, label updates to ensure scalability, audit, and cost-efficient. Labeling represents mainly three aspects of life science companies – Commercial, Research and Supply Chain. A clear strategy is needed for labeling service. Conscientious process design and discipline makes the labeling more creative and unique. It includes designing and writing label contents and mock-up’s. The most challenging significance of labeling service is to ensure the requested label changes, retrieved for regulatory and business impact,and to implement package components correctly.
Tech Tammina offers global and regional labeling services for life science companies. Tech Tammina life science experts manage non-compliant proposed Labeling content. Tech Tammina life science experts provide assistance to draft Investigational Brochure (IB). Our company also develops Core Data sheets and core safety information. Tech Tammina also helps in creating and updating Company Core Data Sheets (CCDS) and Company Core Patient Prescribing Information (CCPPI). We also provide Target Product Profiles (TPP). Tech Tammina works for USA, Europe, Middle East regions. We work under the regulation of global regulatory affairs for delivering the clients hassle-free services for USPI – US Prescribing Information & USPPI US Patient Prescribing Information, EU Summary of products characteristics (SmPCs) and PILS for the rest of the nations.
The major challenges faced by life sciences companies for labeling service are balancing labels across geographical regions, implementing the revised product information, revising CCDS, SmPCs, TPP etc., translating activities and brand comparing. Our company leverage clinical expertise and geographical diversity to work for balancing labels across geographical regions. Our company has highly trained Full-Time Equivalent (FTE) for working on this service. Our company also compares the analysis of local label content and gap analysis. We also manage requests and do document decisions. We implement tracking and integrate product knowledge bases. Tech Tammina also works on product naming as per your company requirements by discussing the products. Tech Tammina also does national submissions of labels of products.
Why Tech Tammina :
- Tech Tammina has highly qualified professionals and uses modern methods for labeling and packaging.
- Customer satisfaction is the first priority of our company. According to client needs and budget, we do deployment of labeling service.
- Tech Tammina works on all types of labeling operations like packaging, bottle labeling.
- We negotiate and interact with Health Authorities (HAs).
- Tech Tammina Regulatory life sciences experts help your company team for label insights and strategy.
- We provide labeling review and compliance.
- Some regulatory agencies require labeling information for the products manufactured. Our company regulatory experts try to support agency.
- Tech Tammina believes in perfection. Instead of delivering blindly the labeling products to the regulatory agencies, we develop and review the medication guides for respective products. The instructions to use are also provided under labeling.
- Major Quality flaws are taken care of by our company.
- Tech Tammina works with the trend. We do help in labeling by using latest designing technology.