Clinical Labeling comes labeling services. Every pharmaceutical manufacturing company needs the labeling services. Every product, every bottle, every shipping box of the pharmaceutical company needs the labeling service. While developing drugs, Companies utilize various labeling tools to showcase the development of drugs and at the same time taking care of marketing and labeling objectives to study design. Some clinical labeling tools are –
- Investigator Brochure. (IB)
- Target Profile.
- Development Core Data Sheet. (DCDS)
- Development of Core Safety Information. (DCSI)
- Target Product Profile. (TPP)
Tech Tammina works in most of the regions in the US. Tech Tammina will provide you ready to use clinical labels for your products.It is very necessary for companies to collect the information related to safety and effectiveness of different types of clinical labeling. The investors and sponsors can have satisfaction when we present an update DCSI that can be placed under various clinical categories. Company Core Data Sheet (CCDS) includes Company Core Safety Information (CCSI) which includes DSCI.
Creating and Reviewing Investigational Brochure (IB) :
For various clinical stages, Tech Tammina has expertise in creating, authorizing and reviewing the Investigational Brochure. To treat physician with information related to drugs and intervention, IB is used as the most elementary forms of labels. Many key features of protocols like dose, dose interval, and information regarding the understanding of the rationale for are the main purpose of IB. IB is used for administering the safety monitoring procedures. The Clinical and the Pre-clinical information corresponds to an investigational drug comes under IB. Tech Tammina regulatory life science experts present the information in IB as most concisely, simply, objectively and in the balance form. While translating the documents we maintain the same qualities. We support the annual review of IBs and authorize IBs. Our company professionals work on revisions as this is necessary for standard procedures established by clients and sponsors.
TPP and dSmPC :
Discussions between Pharmaceutical companies and Health Authorities are facilitated. For such discussions, the Target product profile (TPP) and the Draft Summary Product Characteristics (dSmPC) are used. From pre-investigational new drug application (pre-IND) or Investigational New Drug
(IND) phases through post-marketing programs for indicating changes in labeling, throughout the drug development process, The TPP or dSmPC are used. TPP/dSmPC is used as labeling concepts for drug development program in the pharmaceutical companies. The overall statement of intent of drugs development program is provided by TPP/dSmPC. The information of the drug at a particular phase of development is provided by TPP/dSmPC.
Why Tech Tammina :
- Our company experts are pharmaceutical, biotech and nutrition labeling professionals and have full knowledge of regulatory affairs labeling and packaging, unique designs, and other artwork for clinical and commercial use.
- Our company professionals are technically prowess and we use well-integrated quality systems.
- Our company has highly qualified medical writers to give you the best regulatory labeling experience.
- Tech Tammina regulatory life science professionals are well-versed in open-label studies, non-clinical studies and assure the quality of the designs and packaging and strive to live up to your expectations.
- Guidance for US labeling requirements is provided by our company.
- Our company provides Multi-language translations for the labeling and packaging works.
- Our experts recommend your company for the type of labels that can be perfect for your products.
- IB, TPP, CCDS and many more are provided for your drugs development program trails on time and we follow-up the status after submission to Health Authorities.
- For any clinical trials, we can design and source for labeling and packaging.