Navigating Product Registration for Pharmaceutical Expansion to India

Requirements at a glance


The client is a renowned pharmaceutical company, aimed to expand its operations into the burgeoning Indian market. A critical challenge they faced was navigating the complex product registration process, a fundamental requirement for market entry.
Unraveling the complexity


Navigating the Indian regulatory environment was a daunting task for the client. Unfamiliarity with the system, intricate procedural details, and the potential for language barriers and time zone differences created significant obstacles to obtaining product registration.
Our tailored approach

Strategic Approach & Insights

  • Understanding the intricacy of the situation, we devised a tailored solution that would simplify the product registration process for the client.
  • We carried out a comprehensive analysis of the client’s product portfolio and aligned them with the regulatory requirements laid down by the Central Drugs Standard Control Organization (CDSCO), the governing regulatory body in India.
  • Our team prepared a detailed dossier containing all the necessary information as per CDSCO guidelines. Recognizing the importance of preparedness, we also trained the client’s team to answer potential inquiries from the regulatory body.
Impact delivered

Solution & Results

  • With our expert guidance, the client successfully navigated the product registration process with CDSCO. What could have taken months was efficiently completed within a shorter timeline.
  • Our hands-on approach ensured that all queries from the regulatory body were promptly addressed, thus preventing unnecessary delays. The client was able to focus on other aspects of their business expansion, with the confidence that their product registration was being professionally handled.
  • This strategic handling of the product registration process played a crucial role in the client’s successful market entry. After two years of launching, they secured a remarkable 12% market share in India, achieving their target growth rate of 15% in the second year itself.
Final Analysis


The successful product registration of the client’s pharmaceuticals in India underlines our comprehensive understanding of global market expansion. By effectively navigating the regulatory landscape and expediting the registration process, we facilitated the client’s smooth transition into a new market, setting them up for remarkable growth and success.