Manish Sharma

Founder & CEO

As India cements its position as a global pharmaceutical powerhouse, contributing nearly 20 percent of the world’s supply of finished formulations, the demand for expert guidance in quality and regulatory compliance is more vital than ever. With rapid growth comes looming challenges like regulatory hurdles, high research and development costs, pricing pressures, supply chain disruptions, and the increasing threat of counterfeit drugs. Overcoming these challenges by offering expert consultancy in quality and regulatory compliance is Gxpro Pharma Project Consultants. Established in 2018, this turnkey firm brings over 50 years of combined experience, guiding pharmaceutical, biotech, medical device, and healthcare companies.

With deep industry insight and regulatory expertise, the firm helps clients navigate complex global requirements. It provides tailored solutions for quality systems, manufacturing processes, and facility readiness. Supporting companies in scaling up, preparing for international inspections, and upgrading facilities, Gxpro Pharma Project Consultants ensures strong compliance and continuous improvement in a rapidly evolving pharmaceutical landscape.

A Noteworthy Journey

Manish Sharma, Founder and CEO of the company, who holds a master’s degree in Biotechnology, worked as the Head of Quality for many international pharmaceutical brands for the last 20 years. Later on, he decided to open an end-to-end consultancy firm to provide services related to GMP upgradation, USFDA remediation, green & brown field facility design, engineering and utility design, supplier qualification, regulatory approvals

for international markets, techno-commercial detailing and project centric specially designed feasibility study. On the board of directors, Rajesh Patidar, Swapnil Singh and Zuber Mugal also bring to the table their decade-old experience aiding companies to steer engineering and quality related fronts with a proven track record.

With a formidable team of over 50 dedicated professionals, the firm is proud to introduce itself as one of India's fastest-growing pharmaceutical consultancy firms. Today, it has carved a niche for itself as a dynamic and comprehensive solution provider for the pharmaceutical and life sciences sector.

Gxpro Pharma Project Consultants' rapid growth is a testament to its commitment to excellence and its holistic approach to pharmaceutical project execution. It specializes in delivering end-to-end consulting services that span the entire lifecycle of a pharmaceutical facility and its operations.

Integrated Pharma Solutions

The firm specializes in providing comprehensive solutions across key areas of the pharmaceutical sector. Its core expertise lies in pharmaceutical industry design, offering end-to-end guidance from concept development to detailed engineering for manufacturing facilities, laboratories, and R&D centers. These designs prioritize optimal layouts, efficient workflows, and strict regulatory compliance from inception.

Another major area of focus is GMP upgradation, where the firm supports pharmaceutical firms in modernizing its facilities to meet international GMP standards. These include conducting gap analyses, formulating remediation plans, implementing necessary systems, and providing staff training. Furthermore, the firm’s efforts help clients attain certifications such as WHO-GMP, PIC/S, EU-GMP, USFDA, and MHRA, ensuring full regulatory alignment and operational excellence.

The firm also excels in supplier qualification, establishing robust qualification systems and conducting in-depth audits to verify that suppliers of raw materials, packaging, and services adhere to high quality and regulatory standards. Additionally, it offers regulatory approval services, guiding clients through the intricate processes of dossier preparation, submission strategy, and interactions with both local and global regulatory agencies to secure timely product and facility approvals.

A Competent Team of Seasoned Professionals

At the heart of the firm’s success is its diverse team of engineers, pharmacists, quality assurance specialists, regulatory affairs experts, and project managers, whose collective experience and collaborative spirit drive innovation and deliver measurable results. “We are more than just consultants; we are your strategic partners in building, enhancing, and sustaining compliant and efficient pharmaceutical operations for a healthier tomorrow”, states Manish Sharma.

Full-Spectrum Pharma Service Deliverability

Looking at today’s ever-evolving and highly regulated pharmaceutical industry, successful project execution demands a blend of deep technical expertise, stringent regulatory adherence, and strategic foresight. Whether a client is envisioning a state-of-the-art greenfield facility built from the ground up, or seeking to optimize and enhance an existing brownfield operation, Gxpro Pharma Project Consultants stands as your trusted, end-to-end partner.

The firm offers comprehensive consultancy services that span the entire project lifecycle, from initial conceptualization and feasibility studies to detailed engineering, regulatory submissions, facility commissioning, validation, and post-project operational support. Its dedicated team of seasoned professionals, with over two decades of industry experience, brings unparalleled insights into navigating the complexities of pharmaceutical manufacturing, ensuring the project achieves both operational efficiency and unwavering compliance with global standards such as USFDA, EU GMP, WHO GMP, and PIC/S.

Ensuring End-to-End Quality Standards

Gxpro Pharma Project Consultants sets itself apart in the pharmaceutical consultancy landscape through a unique blend of comprehensive services, regulatory expertise, and client-centric solutions that ensure superior value and measurable results. Unlike consultancies that offer disjointed services, Gxpro delivers true end-to-end turnkey solutions, acting as a single point of contact for every aspect of a project. This integrated approach minimizes coordination challenges, leading to faster project execution and greater efficiency.

Also to note, the firm boasts deep expertise in both Greenfield and Brownfield pharmaceutical projects. For Greenfield developments, Gxpro Pharma Project Consultants designs cutting-edge facilities that align with global regulatory standards while incorporating elements such as energy efficiency and industrial VASTU for operational harmony. In Brownfield scenarios, the firm excels at modernizing existing operations without disrupting ongoing production, identifying bottlenecks, addressing compliance gaps, and implementing targeted upgrades to enhance capacity, compliance, and productivity.

Regulatory compliance is a foundational pillar of Gxpro Pharma Project Consultants' approach. The team possesses in-depth knowledge of international regulatory frameworks and embeds compliance into every layer of design and operations. From conducting GMP audits and gap analyses to managing supplier qualification, Gxpro Pharma Project Consultants ensures that facilities are audit-ready and meet stringent global standards. Their incorporation of Quality by Design (QbD) principles further reinforces quality from the ground up, resulting in robust, efficient manufacturing systems and processes that reduce variability and enhance product integrity.

Gxpro Pharma Project Consultants is particularly adept at guiding first-time pharmaceutical entrepreneurs and diversified investors through their market entry. Through detailed planning, the firm assists in determining optimal investment levels, dosage forms, product types, capacity planning, and plant configuration. It also offers full support for technology transfer and execution while helping establish initial domestic and export sales channels. These strategic onboarding services are underpinned by solid regulatory documentation and certification support, ensuring clients are both compliant and commercially viable from the start.

Furthermore, Gxpro Pharma Project Consultants integrates advanced engineering with operational excellence. The firm goes beyond compliance to deliver sustainable, cost-effective, and efficient pharmaceutical facilities. Its services cover everything from process optimization and equipment selection to utility qualification and supply chain planning. Ultimately, Gxpro Pharma Project Consultants doesn’t just deliver pharmaceutical projects, it creates strategic pathways to sustainable, compliant, and profitable pharmaceutical operations.

Expert Engineering & Compliance Team

The successful execution of pharmaceutical projects demand an integrated approach where robust engineering acumen meets uncompromising quality assurance. Gxpro Pharma Project Consultants are proud to present the dedicated team poised to deliver excellence on your project. Its specialists bring a powerful synergy of profound engineering expertise and rigorous quality assurance leadership, ensuring that every facet of the project is meticulously planned, flawlessly executed, and fully compliant with global pharmaceutical standards.

The firm’s engineering experts possess extensive experience in process design, facility layout, utility systems, HVAC, cleanroom technology, automation and electrical system design. The team is adept at translating complex operational requirements into innovative, scalable, and efficient design solutions, leveraging cutting-edge technologies to optimize your facility's performance and future readiness. It understands the nuances of greenfield/brownfield projects designing from the ground up to integrating new systems into existing infrastructure while maximizing operational efficiency and cost-effectiveness.

Complementing its engineering prowess, quality assurance and regulatory specialists are deeply versed in global cGMP requirements, Quality by Design (QbD) principles, and validation methodologies. The firm has embedded quality into every stage of the project lifecycle, from risk assessments and vendor qualification to detailed validation protocols (IQ, OQ, PQ) and comprehensive documentation. This proactive approach ensures that your facility is not just operational, but also intrinsically compliant, audit-ready, and capable of sustained high-quality production.

Together, this integrated team at Gxpro Pharma Project Consultants is committed to delivering a world-class pharmaceutical facility that adheres to the highest engineering standards and the strictest regulatory requirements. Its collaborative methodology, honed over decades of successful project delivery, ensures seamless communication, efficient problem-solving, and a unified vision focused solely on achieving your project's objectives with unparalleled success. The firm is ready to transform the client’s vision into a compliant, efficient, and commercially viable reality.

Manish Sharma, Founder & CEO, Gxpro Pharma

Gxpro Pharma Project Consultants is expanding its global footprint with strategic collaborations and associate offices across key international markets. The firm now has strong partnerships in Malaysia, Dubai, Portugal, Greece, and China, enabling it to offer seamless, region-specific support to pharmaceutical ventures worldwide. Through these global alliances, Gxpro Pharma Project Consultants continues its mission to make high-quality, compliant pharmaceutical manufacturing accessible and achievable across Europe, Asia, and the Americas.