Overview

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. 

 

Freyr Expertise

Creation and review of Investigational brochure (IB)

Freyr has considerable expertise in the creation, authoring and review of IBs for various clinical stage programs of our clients.  IBs are the most nascent forms of labels, intended to provide the investigator or treating physician with information regarding the drug/intervention. Their purpose is to provide the investigators and others involved in the trial with the information required to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration and safety monitoring procedures. The IB contains pre-clinical and clinical information related to an investigational drug.

While working on IBs, Freyr labeling experts present the information in a concise, simple, objective and balanced form. The same qualities can be considered when translating documents as well. In addition to authoring IBs, Freyr also supports the annual review of IBs and works on revisions, as necessary, in compliance with standard procedures established by clients and sponsors.  

Development of Target Labeling (TL)/ Target Profile

Development and review of DCDS & DCS

Freyr has proven expertise in creating high quality Developmental Core Data Sheets (DCDS). The DCDS is an intermediary core label which plays an important role in deriving content for first- to- file national labels (like USPI, SmPC etc). The DCDS/DCSI is prepared from the target label, and it provides integrated safety and efficacy to an intervention or drug.  The DCDS/DCSI helps investigators and sponsors more effectively by presenting and updating focused, dedicated DCDS sections that can conveniently be placed within the IB. The DCSI help in developing Company Core Safety Information (CCSI), which later forms an integral part of the Company Core Data Sheet (CCDS).

Development and review of FDA Target Product Profile (TPP), EU-draft SmPC (dSmPC)

 Target Product Profile (TPP)/draft Summary Product Characteristics (dSmPC) are a form of label that facilitate the discussions between Pharmaceutical companies and the Health Authorities. The TPP/dSmPc are used throughout the drug development process, from pre-investigational new drug application (pre-IND) or investigational new drug application (IND) phases of drug development through post marketing programs to pursue new indications or other substantial changes in labeling. Pharmaceutical companies specify the labeling concepts that are the goals of the drug development program in the form of TPP/dSmPC. Ideally, TPP/dSmPC provides a statement of the overall intent of the drug development program, and gives information about the drug at a particular phase of development. As a strategic Regulatory partner, Freyr has expertise in preparing Target Product Profiles for the US, and dSmPc for the EU. 

 

Freyr Advantages

  • Resources with in-depth Regulatory knowledge
  • Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients, worldwide
  • Extensive global experience in covering diverse Regulatory domains across Pharma
  • Highly qualified medical writers possessing extensive Regulatory experience
  • In-depth and updated understanding of the global drug labeling changes, as required by local Regulatory authority bodies
  • Dedicated compliance team tracking the status of data sheets implementation in regional labels
  • Highly experienced labeling professionals