Labeling is one of the complex aspects for regulatory life science industry. Organizations must take care that the drug information related to manufacturing, safety, and efficacy which are mentioned on the labels, is controlled by maintaining core reference product information as regulatory requirements are increasing constantly. Labeling is at the forefront of the drug development process. For developing clinical function, drug safety, manufacturing, CMC, the labeling plays a key mediator for all of them. Labeling helps in risk profile development and the subsequent communication cascade. Since, labeling became so important for every aspect of regulatory life science, making it global became very necessary.
Company’s global document for a product is served by an internal regulatory document called Core Data Sheet (CDS). A company’s position is communicated to the appropriate stakeholders worldwide though CDS for the inclusion of safety and efficacy information on country-specific labels. To market a medicinal product worldwide, a core label is prepared before or after the regulatory approval. Investigator Brochure (IB) of a clinical trial derives the primary information of a core label and then more information from Post-marketing sources like Post-marketing safety and efficacy studies and post-marketing surveillance data is added. As an attachment to a Periodic Safety Update Report (PSUR), the Company Core Data Sheet (CCDS) is used. All the safety information or specifically identifies the subset of the safety information is included in this CCDS.
Technology has taken a foothold in global labeling. For global end-to-end labeling programs, Tammina Life Science develops a comprehensive vision and executive strategy with clients. Tammina Life Science also advises clients on the global end-to-end labeling programs like advising on the development and execution of a tactical strategy.With respect to process and content control, the expectations from regulatory bodies like FDA, EMA have grown over the last decade. Clients have always wanted not only operational efficiency but also capability in managing the process, and Tammina Life Science regulatory life science experts try to cope up the expectations.
Advantages of Tammina Life Science :
Tammina Life Science keeps up with the future trends to address future requirements for global labeling. Tammina Life Science does systematic reviews and continuously and updates the inter-company roles, processes, and systems. Tammina Life Science regulatory life science experts have in-depth regulatory knowledge. We have highly qualified medical, pharmaceutical, biotech, and nutrition writers to possess extensive regulatory labeling experience. Manufacturers for Pharmaceutical, biotech, and nutrition and much more life science expertise are covered by our global expertise. Tammina Life Science has a successful record for handling global and regional drug labeling for Fortune Pharma clients across the globe like USA, Europe, and the Middle East etc. Tammina Life Science life science experts have updated understanding and in-depth knowledge of the global labeling changes from multiple Health Authorities such as United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Therapeutic Goods Administration (TGA). Tammina Life Science experts also track the status of core and company Core Data Sheet implementation in regional labels and this is done by our Tammina Life Science dedicated compliance team.
Why Tammina Life Science :
- We have the global level management system for labeling, Label control change, and for Human Authorities query.
- We Create the Investigational Brochures. Updating and reviewing of the IB are also done by our company.
- We create the Company Core Data Sheets. Updating and reviewing of the CCDS are also done by our company.
- We create Reference Safety Information. Updating and reviewing of the RSI are also done by our company.
- We create the Development Core Data Sheet. Updating and reviewing of the DCDS are also done by our company.
- Our company experts prepare the label justification document.
- Core labels like Investigational Brochures (IB), Development Core Data Sheet (DCDS), Core Company Data Sheet (CCDS), Reference Safety Information (RSI), Clinical Overview (CO) goes under the quality check by us.
- Labeling changes are tracked and implemented by our company experts.