Our Team
Meet The Directors
Sandeep Andhari
Promoter & Director
Sandeep Andhari has +10 years of consulting expertise & experience in handling pharma QA/QC, gap assessments, audits, training & regulatory affairs activities. Have pioneered many pharma companies to achieve their goals of producing quality medicines and obtaining regulatory approvals/accreditations. In his consultancy career, he was associated with top regulatory & GMP consulting agencies in the world. He has successfully conducted +250 audits & gap assessments and traveled around the world for auditing & consulting. He is versatile with API and formulation GMP. Sandeep Andhari is nominated as a mentor for Indian Pharmaceutical Industries for the upgradation of quality systems by WHO, JSS & IPA collaborated mentorship program. Earlier in his industry career of +25 years, he had the opportunity to be associated with esteemed organizations including Lupin, Boots, Knoll, Abbott, Sun Pharma, Micro Labs & Astral Steritech. His last position was General Manager -Quality Assurance. He is a CQI & IRCA certified Lead Auditor and has a successful track record in consulting & auditing.
Nitin Lawar
Promoter & Director
Performance-driven industry leader offering over three decades of experience in quality and regulatory affairs across the pharmaceutical industry. Competent in establishing quality standards as per cGXP requirements at the operations and corporate levels. Proficient in building quality culture and quality system remediation for enforcement action. Versatile exposure for all sterile and non-sterile dosage forms. Hosted international regulatory inspections as a key quality capacity. Digitization expert with a success story in implementing eQMS, LIMS, eLAB, SAP, etc as per GAMP. Successful record of auditing and training to ensure the attainment of organizational objectives. Known for risk-based decision-making within the acceptable standards of compliance & regulations. Professional association as a key capacity with the organizations like Lupin, Aurobindo, USV, AstraZeneca, Meiji & Aragen. Instrumental in various continuous improvement projects in life science industries.
Sandeep Andhari
President & CEO- cGxP Lifeline, Mumbai, India
Pharma GMP Consultant, Lead auditor & trainer
Sandeep Andhari is President & CEO of cGxP Lifeline, Mumbai, India, a global pharmaceutical consulting firm specializing in auditing, gap assessment, remediation, digital transformation, and training.
He possesses expertise and extensive experience in handling a broad spectrum of pharmaceutical quality assurance and quality control, International Audits, gap assessments, and Regulatory Affairs activities. In his 35-year pharmaceutical career, he has risen to the top of the ladder of success. He began his entrepreneurial journey in 2012 and mentored small and medium-sized API and formulation units in accelerating compliance and quality culture.
He was associated with esteemed organizations, including Lupin, Boots, Knoll, Abbott, Sun Pharma, Micro Labs & Astral Steritech. His most recent position in the industry was General Manager of Quality Assurance. He has helped pioneer many pharmaceutical companies in achieving their goals of producing quality medicines & obtaining approvals and certifications from the US FDA, MHRA, WHO Geneva, MCC, EDQM, and EXiPACT over the years.
He is a CQI & IRCA Certified Lead Auditor. Additionally, he has successfully conducted over 350 audits & gap assessments, and has traveled worldwide for auditing & consulting purposes. He has worked with top regulatory & GMP consulting organizations like UL Verification Services, Rephine Limited UK, Wave Pharma Regulatory Services UK, Pharmalex India Private Limited & Qualiculture Consulting Group. He is a qualified expert certified by the World Health Organization for pharmaceutical GMP & regulatory training.
He is a consistent performer with a successful GMP consulting & auditing track record spanning over a decade, and has many satisfied clients.

Sandeep Andhari is the President & CEO of cGxP Lifeline, a global pharmaceutical consulting firm based in Mumbai, India. With 35 years of experience in pharmaceutical quality assurance, quality control, regulatory affairs, and international auditing, he has led extensive gap assessments, remediation projects, digital transformation, and technical training initiatives. Since beginning his entrepreneurial journey in 2012, he has mentored numerous small- and medium-sized API and formulation units, helping strengthen compliance and quality culture. His career includes leadership roles at Lupin, Boots, Knoll, Abbott, Sun Pharma, Micro Labs, and Astral Steritech, most recently as General Manager of Quality Assurance. He has conducted over 350 audits worldwide and contributed to companies achieving approvals from the US FDA, MHRA, WHO, MCC, EDQM, and EXCiPACT. He has collaborated with top global GMP consulting organizations and is a WHO-certified expert in pharmaceutical GMP and regulatory training

Performance-driven industry leader offering over three decades of experience in quality and regulatory affairs across the pharmaceutical industry. Competent in establishing quality standards as per cGXP requirements at the operations and corporate levels. Proficient in building quality culture and quality system remediation for enforcement action. Versatile exposure for all sterile and non-sterile dosage forms. Hosted international regulatory inspections as a key quality capacity. Digitization expert with a success story in implementing eQMS, LIMS, eLAB, SAP, etc as per GAMP. Successful record of auditing and training to ensure the attainment of organizational objectives. Known for risk-based decision-making within the acceptable standards of compliance & regulations. Professional association as a key capacity with the organizations like Lupin, Aurobindo, USV, AstraZeneca, Meiji & Aragen. Instrumental in various continuous improvement projects in life science industries.

Yateen Shah is an experienced business professional with 39 years of experience in quality operations, quality systems, and regulatory functions within the Medical devices and Pharmaceutical industries. He is the founder of his proprietary company, “Yateen's MedTech Solutions,” and has partnered with clients to secure ISO certifications, CE marking, US FDA & CDSCO approvals. Yateen has demonstrated expertise in manufacturing quality, design quality, and regulatory affairs, showcasing a proven ability to lead cross-functional processes that adhere to global standards for medical devices and pharmaceuticals. His key skills include leadership, strategic planning, quality management systems, regulatory affairs, IMDR 2017, medical device sterilization, and auditing. Throughout his career, he has undertaken various overseas assignments, including technical training, conferences, and projects. His most recent industry position was as Director of Regulatory Affairs and Commercial Quality at Johnson & Johnson and Ethicon. He is a certified ISO 13485 Lead Auditor and ASQ auditor. Yateen holds a Master of Science degree and an MBA in Marketing.

Nilesh Gandhi is a pharmaceutical regulation and compliance expert with over 25 years of experience. A former Assistant Commissioner (Drugs) with the FDA, Government of Maharashtra, he has led major enforcement actions to protect public health and ensure adherence to drug laws and GMP standards. He holds a B. Pharm, LL.M., and multiple specialized certifications, including CQI-IRCA Lead Auditor and WHO consultant credentials. Nilesh has conducted numerous WHO-GMP and Schedule M audits and trained regulatory officers across India and Southeast Asia. He has received several honors, including the AIDCOC Best Drugs Inspector Award, FDA Person of the Year (2007), and the IPGA Fellowship Award (2024). Co-author of the leading legal reference commentary on the Drugs and Cosmetics Act, he currently leads Pharm Astute and works with Pharmalex, providing regulatory, legal, and compliance expertise.
✨ A Message from Our Board
To ensure that every solution we deliver helps create safer, more compliant, and more efficient pharmaceutical systems globally. We believe in partnership, in transparency, and in empowering organizations to build systems that withstand regulatory scrutiny while delivering consistent product quality. Thank you for placing your trust in us. We are excited to support your journey toward global compliance and operational excellence.












