Clinical Labeling Services, Drugs, FDA Target product Profile

During drug development, companies may utilize a variety of labeling-related tools that employ target labeling to facilitate drug development, while simultaneously aligning desired marketing and labeling objectives with the development program design or study design. Some of the clinical labeling tools utilized during drug development are:

• Investigator Brochure (IB)

• Target Labeling (TL)/ Target Profile

• Development Core Data Sheet (DCDS)

• Development Core Safety Information (DCSI)

• FDA Target Product Profile (TPP)

It is very important for companies to employ a modular approach while collecting the evolving safety and efficacy information across various types of clinical labels. This would satisfy the need to help investigators and sponsors more effectively by presenting and updating a focused, dedicated DCSI section that can conveniently be placed under these different clinical categories. Furthermore, DCSI develops into the CCSI that is included in the first Company Core Data Sheet (CDS) and is utilized for the product's entry into the market.

To navigate organizations through Regulatory requirements, Freyr offers specialized clinical labeling services.