CONSULTING SERVICES
About Us
PharmAdvis Solutions LLP is a client-focused consulting firm dedicated to providing comprehensive regulatory, quality management, and training services to pharmaceutical companies worldwide. With a strong commitment to excellence and innovation, we strive to help our clients navigate the complexities of global regulatory environments and ensure full compliance with industry standards. Our mission is to empower our partners by delivering tailored, efficient, and strategic solutions that drive both regulatory success and operational efficiency.
Mr. Rajeev C. Paliwal, Co-Founder of PharmAdvis Solutions LLP
Mr. Rajeev Paliwal is a quality management and regulatory affairs veteran with over 34 years of experience. Having worked with leading companies such as Teva, Mylan, Wockhardt, and Lupin, he has successfully overseen more than 75 regulatory audits from bodies like the USFDA and MHRA. His expertise lies in GMP remediation, risk management, inspection readiness, and quality systems development. Mr. Paliwal has played a key role in strategic collaborations with global consultants and has participated in audits, regulatory inspections, and due diligence in countries like the USA, Israel, and Germany. He holds a Master’s degree in Pharmaceutics from BIT, Mesra and has a proven track record of ensuring quality compliance for global firms.
Dr.Prafulla Nandi, Co-Founder of
PharmAdvis Solutions LLP
Dr. Prafulla Nandi brings over 32 years of expertise in the field of Pharmaceutical Research and Global Regulatory Affairs. He has successfully led the development and registration program of several pharma majors worldwide. Worked with major pharmaceutical organizations such as Apotex, Fresenius Kabi, Dr. Reddy’s, Torrent, Jubilant, Laurus and Cadila Pharma (as Joint President). Dr. Nandi has vast international exposure, having engaged with international regulatory bodies such as the USFDA, EMA, HPB, TGA and WHO across countries including the USA, EU, Canada, and Australia. His extensive network and strategic collaborations with global consultants have ensured seamless regulatory compliance for his clients. Dr. Nandi holds a Master’s degree from BITS, Pilani and PhD from Utkal University, BBSR.
HOW WE CAN Assist
We’ll make sure you stay focused on the opportunities.
End-to-end programs
PharmAdvis Solutions LLP is a client-focused consulting firm dedicated to providing comprehensive regulatory, quality management, and training services to pharmaceutical companies worldwide. We help you to navigate the complexities of global regulatory environments while ensuring you to stay focused on the opportunities that drive growth. With our end-to-end programs, we streamline every aspect of your operations, from regulatory submissions and GMP compliance to quality systems and post-approval requirements. Our expert team, with extensive industry experience, is committed to deliver tailored made solutions that ensure your compliance and operational excellence, allowing you to prioritize innovation and market expansion.
Industry Expertise
Our team consists of seasoned professionals with extensive experience across multiple facets of the pharmaceutical industry, including regulatory affairs, quality management, product development, and pharmacovigilance. Our experts bring decades of hands-on experience, having worked with leading multinational corporations and regulatory agencies worldwide. We understand the unique challenges pharmaceutical companies face, and our expertise spans across major global markets including the U.S., Europe, Asia-Pacific, and emerging markets.
Commitment to Excellence
Our focus on delivering quality and excellence is at the core of everything we do. We are committed to providing results-driven services that not only meet regulatory requirements but also support the operational growth of our clients. From improving quality systems to enhancing inspection readiness, our solutions are designed to elevate the standards of compliance and efficiency in every aspect of your business.
Tailored Solutions
At PharmAdvis, we recognize that no two companies are alike. Our solutions are fully customizable to address the specific needs, objectives, and challenges of each client. Whether you are looking for support with regulatory submissions, GMP compliance, or comprehensive quality systems, we provide solutions that are uniquely designed to meet your organization’s goals.
Global Reach and Collaboration
PharmAdvis has built a network of strategic partnerships and collaborations with leading global consultants and regulatory experts. This enables us to stay at the forefront of evolving regulations and deliver insights on emerging trends. We work closely with clients and regulatory agencies to streamline processes, foster innovation, and ensure successful market entry.
Proven Track Record:
PharmAdvis Solutions LLP takes pride in its proven track record of success. We have managed over 500 regulatory submissions across a wide range of regions and regulatory authorities, consistently achieving successful approvals. Our experience spans a variety of regulatory pathways, including orphan drug designations, fast-track approvals, biosimilar registrations, and lifecycle management filings. We are adept at handling complex submissions and ensuring compliance throughout the entire product lifecycle.
Innovative Solutions for Future Growth
At PharmAdvis, we are committed to helping our clients not only meet today’s regulatory challenges but also stay ahead of future developments. By integrating cutting-edge technologies, data-driven insights, and industry foresight, we provide innovative solutions that enhance product lifecycle management, operational efficiency, and regulatory compliance. Our proactive approach ensures that our clients are well-prepared for upcoming trends and market shifts in the pharmaceutical landscape.
Numbers
Client results
Unlocking Success Through Strategic Mentorship
By leveraging industry expertise and knowledge of global regulations, mentoring and consulting ensure timely and smooth regulatory submissions, helping companies avoid delays and costly mistakes.
Yes, consulting services identify gaps in processes, streamline workflows, and implement effective quality management systems, boosting overall productivity and efficiency.
With experience across multiple markets, mentoring offers insights into region-specific regulatory requirements, ensuring compliance with diverse standards like FDA, EMA, and MHRA.
By developing risk-based quality systems, consulting ensures thorough risk assessments, root cause analysis, and corrective actions, enhancing product safety and regulatory compliance.
Absolutely. Consulting services include mock audits, gap assessments, and training programs to ensure teams are well-prepared for regulatory inspections, reducing the risk of non-compliance.
By offering strategic guidance and insights, mentoring helps companies navigate regulatory pathways for innovative products like orphan drugs and biosimilars, accelerating approvals.
Yes, consulting provides continuous support for post-approval filings, variations, renewals, and lifecycle management, ensuring ongoing compliance with regulatory agencies.
Mentoring and consulting focus on skill development through targeted training programs, empowering teams to handle regulatory challenges with confidence and efficiency.
With tailored strategies, mentoring aligns regulatory and quality management goals with business objectives, fostering sustainable growth and competitive advantage.
Experienced consultants bring real-time regulatory intelligence and global market insights, enabling informed decisions that mitigate risks and capitalize on opportunities.