Your Trusted Partner in Regulatory Compliance

Simplifying complex regulatory journeys across Drugs, Medical Devices, Biologicals, IVDs, Nutraceuticals, Food, and Cosmetics industries

Empowering Regulatory Compliance Since 1995

Welcome to AKB Consultancy, a leading regulatory affairs specialist with over 25 years of industry experience. Established in 1995, we have consistently helped numerous domestic and international organisations set up, sustain, and grow their businesses. Our dedicated team is committed to simplifying, guiding, and empowering our clients throughout their entire regulatory journey, ensuring compliance and peace of mind at every step of the way

1995

EXPERIENCE SINCE YEAR
WHY US

Why Choose AKB

Unrivalled 
Experience

Over 25 years in the industry, with our proprietor Mr. A K Bhandari bringing over 45 years of Pharma industry experience. Our well-qualified staff boast over 100+ years of combined industry experience

Specialized Expertise

A dedicated practice specialising in advising clients on regulatory relationships, offering comprehensive and tailored solutions

Holistic Support

Whether navigating complex registration processes, obtaining import licences, securing manufacturing licences, or facilitating performance evaluations, we provide expert support and assistance

Client Centric Approach

We empower you to focus on your core business with confidence, handling your regulatory needs with utmost data privacy and confidentiality

Our Expertise Covers

At AKB Consultancy, we specialize in navigating the complexities of regulatory compliance across various industries. Our expert team is dedicated to ensuring your products meet all necessary regulations, allowing you to focus on growth.

Regulatory Affairs for Drugs and Medical Devices & IVDs

We provide expert guidance for drug and medical device registration.

Comprehensive Support for Biologicals, rDNA, Vaccine, Stemcell & Blood Products

Our team ensures compliance for biological products and in vitro & vivo diagnostics.

Expertise in Nutraceuticals, FSSAI, & Cosmetics

We help navigate the regulatory landscape for nutraceuticals, FSSAI, and cosmetics.

Veterinary Product approval & Import Registration of Veterinary products

Full-service veterinary regulatory support ensuring animal health products meet safety standards and achieve market clearance.

Written Confirmation & Ethics Committee Approvals

Professional documentation and ethics coordination ensuring regulatory compliance and ethical standards for research and development.

NOC for BA, BE Study & BA/BE Centre Approval

Expert bioavailability and bioequivalence study support, facilitating center approvals and regulatory clearances for clinical research.

New Drug Permission, SND & FDC

Streamlined new drug applications , subsequent new drugs and combination products, ensuring compliance and accelerated approval timelines.

Global Clinical Trails Applications

International clinical trial management coordinating multi-jurisdictional approvals and ensuring compliance across global regulatory frameworks.

Testimonials

AKB Consultancy transformed our regulatory approach.

Our Clientele

We serve as Indian Agents in Regulatory Compliance

Indian Agents serve as the regulatory bridge between international companies and the Indian market, ensuring seamless compliance with local healthcare regulations.

CKD Bio Corp, Korea

The company is specialized in Contract Manufacturing and Contract Research in fermentation and chemical synthesis, providing various antibiotic materials used in medical pills and medical components.

As their exclusive Indian regulatory agent, A K Bhandari Consultancy facilitates CKD Bio Corp's market entry into India by providing comprehensive regulatory support for their pharmaceutical products, probiotics, and fermentation-based medicines.

Uptake Medical, USA

Uptake Medical Technology Inc. is a medical device company based in San Jose, CA, USA, dedicated to improving the lives of patients suffering from pulmonary disease with vapor ablation

As their authorized Indian regulatory representative, A K Bhandari Consultancy supports Uptake Medical's expansion into the Indian market by managing all regulatory requirements for their innovative pulmonary medical devices.

Ready to Elevate Your Business?

Contact us today for expert guidance on your regulatory journey and tailored solutions.