A.K. Bhandari

Proprietor

India’s pharmaceutical consulting market operates within one of the most tightly regulated industrial en vironments. Regulatory norms continue to intensify, compliance requirements grow more complex, and fre quent policy updates demand constant vigilance. In such a dynamic ecosystem, regulatory knowledge alone no longer suffices. Additionally, success increasingly depends on the ability to interpret regulations correctly and apply them effectively through real-world submission experience.

These conditions create significant challenges for pharmaceutical companies. Compliance lapses, operational missteps, or delays in regulatory approvals can directly block market access. Furthermore, marketing authorization remains the most critical gateway, requiring absolute adherence to every development and regulatory milestone, with little margin for error.

Positioned at this intersection of regulation and execution, AKB Consultancy plays a defining role. The firm partners with pharmaceutical companies across every stage of the regulatory journey, ensuring no step is missed and compliance remains intact throughout. Through structured guidance, regulatory precision, and consistent follow-through, the consultancy enables clients to approach market access with confidence, clarity, and control. 

A Noteworthy Journey

AKB Consultancy’s journey began back in 1995 with a clear purpose to navigate the complexities of India’s regulatory landscape with integrity and precision. From its early days, the consultancy focused on building deep, dependable partnerships rather than chasing rapid expansion. This approach laid the foundation for a presence that has grown steadily over the decades.

As the years progressed, it went on to serve more than 25 clients, a milestone defined not by numbers alone but by continuity. Every client that joined the firm in its formative years continues to work with it today, a testament to consistent delivery and enduring trust. Growth followed naturally, driven almost entirely by referrals from satisfied clients who placed complete confidence in the firm’s capabilities and its people. “Transparency, truthfulness, and unrelenting effort form the mission that guides our operations and client relationships,” states A.K. Bhandari, Proprietor at AKB Consultancy.

A Meticulous Approach

Today, AKB Consultancy delivers end-to-end project consultancy for new drug approvals across human and veterinary segments. The consultancy also supports registrations for medical devices, cosmetics, and related products, including assistance with commercial import licenses and their timely renewals to ensure uninterrupted market presence. 

Additionally, the consultancy manages all post-approval submissions and supports clients in securing permissions to conduct clinical trials in India. It also facilitates FSSAI  product licenses for nutraceuticals. Acting as a critical interface between clients and regulatory authorities, AKB Consultancy represents clients during submissions and follow-ups. With most filings now routed through online platforms, the consultancy actively supports accurate and timely digital submissions. 

Notably, public health remains central to AKB Consultancy’s philosophy, with no compromise on the quality of medicines. In total, the consultancy remains committed to supporting clients that bring innovative, safe, and effective therapies to the Indian market, reinforcing its long-term role in strengthening the pharmaceutical ecosystem.

Team Expertise

Behind AKB Consultancy’s consistent regulatory outcomes stands a team shaped by experience and technical depth. Over the years, the team has developed a thorough understanding of regulatory frameworks, application pathways, and documentation requirements across categories. This knowledge allows them to anticipate challenges early and maintain tight compliance control long before an application reaches submission. 

Every engagement begins with careful scrutiny. The team reviews each application element in detail, examining documentation with a critical eye. When gaps appear, the team communicates transparently, informing clients upfront and guiding them through the necessary corrections. Only when every requirement aligns with regulatory expectations does the team move forward, ensuring each submission reflects precision, preparedness, and reliability.

Driving the Needed Innovation

AKB Consultancy uses modern IT tools to strengthen data management, cataloging, and archiving. These systems improve accuracy, accessibility, and speed across regulatory projects. 

Moreover, the consultancy treats the CDSCO portal as the most accurate representation of client project status. By maintaining complete visibility on this platform, the consultancy ensures collaborative transparency and keeps clients aligned with real-time regulatory progress. 

A Robust Future Roadmap

AKB Consultancy plans to continue along its established growth path. It intends to modernize customer outreach efforts while retaining word-of-mouth referrals as its most effective expansion strategy. At the same time, the consultancy will further strengthen and modernize its IT infrastructure. On the whole, the consultancy will continue onboarding competitive talent with deep regulatory affairs expertise, ensuring sustained quality, capability building, and long-term relevance.