Dr Prasad
Dr Prasad
Dr. Prasad is an innovator in pharmaceutical research and development, with over 20 years of experience as a pharmaceutical scientist and R&D leader. He has driven advancements across drug delivery systems, nanotechnology, biomaterials, tissue engineering, regenerative medicine, and oral thin-film technology.
Currently serving as Director at LN Pharmaceuticals, he leads innovation in advanced healthcare solutions, transforming ideas into safe, effective, and commercially viable products. His work has a strong focus on oral thin films for pharmaceuticals and nutraceuticals—delivering wellness through convenience, precision, and rapid absorption. Dr. Prasad has authored over 50 research publications and holds more than 40 patents.
He is passionate about bridging science and consumer health, driving innovations that simplify wellness and improve lives.
Dr Prasad
Dr Prasad
Dr. Prasad is an innovator in pharmaceutical research and development, with over 20 years of experience as a pharmaceutical scientist and R&D leader. He has driven advancements across drug delivery systems, nanotechnology, biomaterials, tissue engineering, regenerative medicine, and oral thin-film technology.
Currently serving as Director at LN Pharmaceuticals, he leads innovation in advanced healthcare solutions, transforming ideas into safe, effective, and commercially viable products. His work has a strong focus on oral thin films for pharmaceuticals and nutraceuticals—delivering wellness through convenience, precision, and rapid absorption. Dr. Prasad has authored over 50 research publications and holds more than 40 patents.
He is passionate about bridging science and consumer health, driving innovations that simplify wellness and improve lives.
Mr. Vijay Kshirsagar
Mr. Vijay Kshirsagar
Vijay is an accomplished Quality, Regulatory & Analytical professional with more than 38 years of rich experience of working for reputed Indian, MNC Pharma firms & then as a Consultant for nearly 11 years. His last stint was with Unichem as Executive Vice President responsible for CQA, Regulatory & Analytical Research. Later he continued as Advisor for Unichem on Quality & Regulatory matters till 2023.
Prior to Unichem he worked for Ranbaxy, Sun , Tata-Merind, IPCA, German Remedies, Lupin & Duphar Interfran in various Senior positions like Director-Quality , GM-Quality etc . He has successfully represented his company in US and UK courts regarding IP related matters (Para IV filings). He has a unique achievement of converting existing Cephalosporin facility to a general product facility & getting it approved by MHRA (first time in India).
Vijay has led from front for successful completion of several regulatory inspections by US FDA, MHRA, EDQM, ANVISA, WHO, PICS, PMDA, Health Canada, TGA both for DP (Non-Sterile& Sterile) & API’s.
He has been a frequent auditor & trainer in India & abroad. He has spoken on wide range of topics including cGMP/GLP/ QbD/PQS/ QRM/ Validations / Investigations/Aseptic Techniques /QbD/Dissolution Stability/Regulatory/Auditing/Documentation/Productivity etc. He has spoken in number of national and international forums including SPDS/ISPE/CPHI/USP/IDMA/ HRDF etc. He is the founder President of ‘Society for Pharmaceutical Dissolution Science’ (SPDS) which is now a global platform. He was conferred upon “Leadership Award” by SPDS. He has also worked on the board of Directors of ISPE-India for 12 years. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis. He was also conferred upon Certificate of Honor by USP India for leading USP Regional Stakeholders Forum He has published articles on topics like OOS, QbD & cGMP in reputed journals/text books.
Guideline written by him on CAPA is published by IDMA. He is M.Sc. by Research in OrganoAnalytical Chemistry from Mumbai University. He has a good Microbiological background too having done his graduation with Microbiology. He is also an Advisor/ Mentor to two reputed pharmacy colleges in Mumbai.
Post 2013, he has formed his own Mumbai based Pharma Consultancy called TRAC offering specialized services globally for cGMP Training, Regulatory Services, Auditing & Compliance. TRAC was selected as amongst top 10 His current clients include reputed Pharma/API companies based in India, China, Malaysia, Bangladesh, Turkey, US, Europe etc. TRAC received an award from India Pharma Outlook as amongst Top 10 Pharma Consulting Companies in Oct 2024. TRAC has helped number of companies to get their first time international regulatory approvals & also sustain them over a long period. He has successfully helped the companies for their remediation plans to revive their regulatory approvals (Post WL/Import Ban).
Mr. Vijay Kshirsagar
Mr. Vijay Kshirsagar
Vijay is an accomplished Quality, Regulatory & Analytical professional with more than 38 years of rich experience of working for reputed Indian, MNC Pharma firms & then as a Consultant for nearly 11 years. His last stint was with Unichem as Executive Vice President responsible for CQA, Regulatory & Analytical Research. Later he continued as Advisor for Unichem on Quality & Regulatory matters till 2023.
Prior to Unichem he worked for Ranbaxy, Sun , Tata-Merind, IPCA, German Remedies, Lupin & Duphar Interfran in various Senior positions like Director-Quality , GM-Quality etc . He has successfully represented his company in US and UK courts regarding IP related matters (Para IV filings). He has a unique achievement of converting existing Cephalosporin facility to a general product facility & getting it approved by MHRA (first time in India).
Vijay has led from front for successful completion of several regulatory inspections by US FDA, MHRA, EDQM, ANVISA, WHO, PICS, PMDA, Health Canada, TGA both for DP (Non-Sterile& Sterile) & API’s.
He has been a frequent auditor & trainer in India & abroad. He has spoken on wide range of topics including cGMP/GLP/ QbD/PQS/ QRM/ Validations / Investigations/Aseptic Techniques /QbD/Dissolution Stability/Regulatory/Auditing/Documentation/Productivity etc. He has spoken in number of national and international forums including SPDS/ISPE/CPHI/USP/IDMA/ HRDF etc. He is the founder President of ‘Society for Pharmaceutical Dissolution Science’ (SPDS) which is now a global platform. He was conferred upon “Leadership Award” by SPDS. He has also worked on the board of Directors of ISPE-India for 12 years. IDMA has conferred upon him an ‘Outstanding Analyst Award 2011’ for his contribution towards pharmaceutical analysis. He was also conferred upon Certificate of Honor by USP India for leading USP Regional Stakeholders Forum He has published articles on topics like OOS, QbD & cGMP in reputed journals/text books.
Guideline written by him on CAPA is published by IDMA. He is M.Sc. by Research in OrganoAnalytical Chemistry from Mumbai University. He has a good Microbiological background too having done his graduation with Microbiology. He is also an Advisor/ Mentor to two reputed pharmacy colleges in Mumbai.
Post 2013, he has formed his own Mumbai based Pharma Consultancy called TRAC offering specialized services globally for cGMP Training, Regulatory Services, Auditing & Compliance. TRAC was selected as amongst top 10 His current clients include reputed Pharma/API companies based in India, China, Malaysia, Bangladesh, Turkey, US, Europe etc. TRAC received an award from India Pharma Outlook as amongst Top 10 Pharma Consulting Companies in Oct 2024. TRAC has helped number of companies to get their first time international regulatory approvals & also sustain them over a long period. He has successfully helped the companies for their remediation plans to revive their regulatory approvals (Post WL/Import Ban).
Dr. Prakash Muthudoss
Dr. Prakash Muthudoss
Dr. Prakash is a Chartered Chemist certified by the Royal Society of Chemistry (UK), with over 20 years of R&D experience across leading global organizations, including AstraZeneca (UK), Smith & Nephew (UK), Sanofi (India), Dr. Reddy’s (India), and Novugen (Malaysia). In his current role, Dr. Prakash serves as Director and Chief Scientific Officer at A2Z4.0 Research & Analytics Private Limited. At A2Z4.0, he leads M.A.D. Science—Material & Characterization Science, Applied Data Science, and Decision Science—focused on translating science into strategy for industry, academia, and society.
He supports industries across pharmaceuticals, Ayurveda, medical devices, and food sectors in solving complex R&D and product development challenges. His scholarly contributions include 15+ research papers, three book chapters, and one patent.
He has recently been accepted as an Expert Member of the Green Chemistry Working Group of the Indian Pharmacopoeia Commission (IPC).
He is a Governing Council Member at PSG College of Pharmacy and a Member of the Board of Studies for Pharmaceutical Engineering (BTech) and Pharmaceutical Biotechnology (MTech) at Anna University, Chennai. He also serves on the Board of Studies in Computer Science and Data Science (SSN) and Chemistry (Vel Tech).
He actively collaborates with CSR teams at ICCW (IIT Madras) and Caliber Technologies to upskill underprivileged youth, marginalized communities, and women returning to the workforce through impactful, transformative programs.
Dr. Prakash Muthudoss
Dr. Prakash Muthudoss
Dr. Prakash is a Chartered Chemist certified by the Royal Society of Chemistry (UK), with over 20 years of R&D experience across leading global organizations, including AstraZeneca (UK), Smith & Nephew (UK), Sanofi (India), Dr. Reddy’s (India), and Novugen (Malaysia). In his current role, Dr. Prakash serves as Director and Chief Scientific Officer at A2Z4.0 Research & Analytics Private Limited. At A2Z4.0, he leads M.A.D. Science—Material & Characterization Science, Applied Data Science, and Decision Science—focused on translating science into strategy for industry, academia, and society.
He supports industries across pharmaceuticals, Ayurveda, medical devices, and food sectors in solving complex R&D and product development challenges. His scholarly contributions include 15+ research papers, three book chapters, and one patent.
He has recently been accepted as an Expert Member of the Green Chemistry Working Group of the Indian Pharmacopoeia Commission (IPC).
He is a Governing Council Member at PSG College of Pharmacy and a Member of the Board of Studies for Pharmaceutical Engineering (BTech) and Pharmaceutical Biotechnology (MTech) at Anna University, Chennai. He also serves on the Board of Studies in Computer Science and Data Science (SSN) and Chemistry (Vel Tech).
He actively collaborates with CSR teams at ICCW (IIT Madras) and Caliber Technologies to upskill underprivileged youth, marginalized communities, and women returning to the workforce through impactful, transformative programs.