cyber security

Regulatory Environment Analysis

Home » Info » Regulatory Environment Analysis

Rapidly changing global regulations and several countries adopting stringent regulatory policies are creating several challenges for pharmaceutical companies. This dynamic nature is one of the main reasons due to which multinational companies face difficulties in distribution and marketing which frequently results in monetary losses.  However, global The International Council for Harmonization (ICH) guidelines and countries shifting towards CTD/eCTD plan assists to harmonize regulatory strategy implementation in the pharmaceutical market. The complexities associated with regional regulatory policies largely increase challenges and apart from specific cohesions, each country is individually handled significantly affecting the following timelines and compliance cost. On the other hand, a few challenges are region-specific associated with the local GMP requirements, partially-regulated, non-standardized documentation, multi-agency interactions & involvements, language complexities, import and export licenses, and regularized biological samples among others. Our team of highly experienced members who carry specific expertise related to regulatory policies in most of the largest pharmaceutical markets assists our clients in designing strategies to efficiently handle regulatory policies.

There are a few areas with which we usually assist to our clients such as:

  • Adoption of a centralized and universal regulatory strategy
  • Significant transformation should be carried out in regulatory data management process
  • Integrated data management due to the presence of cross-functional teams across the countries
  • Growth functions should be identified and focused