Ensuring Compliance and Facilitating Communication through Indian Authorized Representation Service

Requirements at a glance

Overview

The client, an established pharmaceutical company, was eager to enter the Indian market but was challenged by the need to appoint a trustworthy local representative to liaise with the regulatory body and ensure local compliance.

Unraveling the complexity

Challenge

One of the critical requirements for foreign businesses entering the Indian market is to have an Authorized Indian Representative. This representative serves as the primary point of contact with the Central Drugs Standard Control Organization (CDSCO) and other local entities. The client was faced with the challenge of finding a reliable representative who could handle this responsibility while ensuring full compliance with Indian regulations.

Our tailored approach

Strategic Approach & Insights

We recognized the importance of this role in the client’s expansion plans and offered our Indian Authorized Representation Service. Our deep understanding of the local regulatory landscape and proven track record in the field positioned us as the ideal partner for the client.
Impact delivered

Results

We became the client’s Indian Authorized Representative, serving as the primary liaison between the company and the CDSCO, and ensuring compliance with local regulations.

Our team ensured seamless communication, promptly addressed any inquiries from the regulatory body, and maintained the required documentation. This allowed the client to focus on their core business operations without worrying about local compliance issues.

Our efficient and professional handling of this role played a significant part in the client’s success in the Indian market. It allowed for a smoother transition into the new market, and the client was able to avoid any regulatory hiccups, which could have potentially delayed their operations.

Within two years of launch, the client had secured a significant 15% market share, surpassing their growth target by 10%. They also received positive feedback from local partners and regulatory bodies, acknowledging the smooth communication and prompt responses, further strengthening their market position.

Final Analysis

Conclusion

By stepping in as the client’s Indian Authorized Representative, we not only ensured compliance with local regulations but also facilitated seamless communication between the client and the regulatory body. Our expertise in managing local representations helped the client focus on its core business and played a vital role in their impressive performance in the Indian market.

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