We deliver solutions that are not only technically sound but also executable and sustainable across the full product lifecycle
Dr Gautam Samanta, Founder
The pharmaceutical and life sciences consulting industry is changing fast, driven by new technology, stricter regulations, shifting markets and a focus on patient care. In India, the sector is moving from a generics-led model to innovation, with growth in biosimilars, complex generics and biotech startups.
Globally, demand is rising for personalized medicine, digital tools and advanced therapies like cell and gene treatments, creating a need for expertise in AI-driven R&D, analytics, market access and regulations. Pharma companies face challenges such as delayed development, inefficient tech transfer, quality gaps, data integrity issues, and skill shortages.
Amidst this challenging landscape, AGS Pharma Consulting helps tackle these challenges with tailored, science-based solutions that speed timelines, cut costs, improve compliance and build in-house capabilities through hands-on support and training.
Noteworthy Growth Journey
AGS Pharma Consulting's growth has been guided by its mission to empower pharmaceutical and biotech companies with practical, science-based, and sustainable solutions. True to its name, Accelerated Growth and Sustainability, the firm focuses on bridging the gap between regulatory expectations and operational realities, delivering long-term solutions to critical development and manufacturing challenges.
The company is led by Dr Gautam Samanta, Founder at AGS Pharma Consulting, a performance-driven senior industry leader with over 30 years of combined experience in academia. He is also serving as Research Assistant Professor at the University of Houston, USA and in the pharmaceutical industry with organizations such as Dr Reddy’s Laboratories and Cipla Limited.
Over the course of his career, Dr Samanta has played a pivotal role in developing robust, high-quality pharmaceutical products and is widely recognized as one of the pioneering scientists to introduce and implement the Quality by Design (QbD) framework in the Indian pharmaceutical sector.
His expertise and contributions to pharmaceutical science are reflected in numerous publications in respected international journals, including Organic Process Research & Development, AAPS PharmSciTech, and Journal of Chromatography A. His work showcases how QbD and Process Analytical Technology (PAT) can be applied to design sustainable, high-performance drug substances and products with strong regulatory assurance.
Notably, Dr Samanta has successfully implemented PAT at a commercial scale, ensuring consistent product quality while minimizing batch failures. Over his career, he has authored more than 50 peer-reviewed articles, some featured in Nature along with seven book chapters and three process patents, further cementing his standing as a thought leader in the field.
“At AGS Pharma Consulting, our mission is to bridge the gap between scientific theory and practical application; we deliver solutions that are not only technically sound but also executable and sustainable across the full product lifecycle”, said Dr Gautam Samanta.
We deliver solutions that are not only technically sound but also executable and sustainable across the full product lifecycleDr Gautam Samanta, Founder
Comprehensive Development Solutions
AGS offers end-to-end product development support for the pharmaceutical, biotechnology, specialty chemicals, fine chemicals and food industries, built on advanced science-driven methodologies. At the core is Quality by Design (QbD), supported by Design of Experiments (DoE), Process Analytical Technology (PAT), Quality Risk Management (QRM) and Statistical Process Control (SPC) to ensure robust, compliant and efficient development and manufacturing.
For commercialization, scale-up strategies ensure smooth transition of active pharmaceutical ingredient (API) processes from laboratory to pilot or full-scale production without compromising quality or efficiency.
Moreover, the firm’s service scope extends beyond conventional consulting, offering solutions that enhance cost efficiency, product quality, operational performance and process scale-up for active pharmaceutical ingredients (API). The firm focuses on optimizing both development and manufacturing to deliver robust, sustainable, and compliant outcomes.
Today, pharmaceutical and biotech companies choose AGS Pharma Consulting for its specialization in QbD, DoE, PAT, risk management and technology transfer. The firm delivers customized, hands-on strategies aligned with operational goals and regulatory expectations, driving measurable results.
Through personalized workshops, practical DoE sessions, PAT implementation and on-site mentoring, the firm builds lasting internal capabilities and helps clients move from molecule to market with clarity, structure and speed.
Client-Centric Support
AGS Pharma Consulting delivers hands-on, responsive support tailored to each client’s unique challenges, be it accelerating development, resolving quality or yield variability or building internal capabilities. Operating on-site or remotely, the team implements structured plans with regular touchpoints and real-time troubleshooting to ensure seamless execution. Trust, compliance and consistent value form the foundation of every client relationship.
Clear communication, realistic timelines, and transparent dialogue guide all engagements, while staying compliant at all times. This covers data integrity, documentation and regulatory readiness and is embedded into every solution. By integrating closely with client teams, co-creating solutions and enhancing skills through targeted workshops and real-time implementation, the firm drives measurable progress and fosters lasting partnerships.
Innovation-Driven Excellence
Research and innovation drive AGS Pharma Consulting’s value delivery. Its methodologies, grounded in best practices, are continuously refined through research, industry engagement and client feedback.
By applying advanced QbD modeling, leveraging real-time-release-testing tools for consistent product quality and aligning with evolving FDA and EMA guidance, the firm ensures solutions are scientifically robust and future-ready. Furthermore, innovation is embedded into process design, risk management and lifecycle strategies, enabling clients to remain compliant, competitive and ahead of the curve.
A Robust Future Roadmap
AGS Pharma Consulting's strategic vision focuses on expanding its impact, enhancing expertise and building stronger global partnerships. The firm is broadening its portfolio to serve basic chemical industries, specialty chemicals and agrochemicals, aligning with sustainability and evolving client needs.
Investments are underway in developing digital tools and templates to streamline quality risk management and QbD frameworks, enabling faster & efficient decision-making and documentation. Training expansions through virtual academies, on-site workshops and e-learning modules will continue to build long-term internal capabilities for clients.
Additionally, the firm aims to be a strategic ally, helping clients lead in science, navigate regulations confidently and operate sustainably, while growing smarter, faster and more globally connected without compromising its personalized high-integrity service.
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