Manish Yadav
2 Courses • 1 StudentBiography
Manish Singh Yadav
BioPharma & Water Quality Consultant. GLP, NABL & GCP Auditor. Lead Trainer – WHO, CSE & JJM.
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· CEO – ETHIXINN Consulting & Research Solutions, India. · WHO Advisor & Trainer – APAC, WHO Geneva. · Authorized Lead Trainer – JJM-CSE, Ministry of Jal Shakti. · Train The Trainer – LSSSDC, India. · Chair – Regulated Bioanalysis, BSAT-APA-INDIA 2015. · 50 International Research Publications. · 25 Years Pharma R&D Expert – BE&CL Trials, Bioanalysis, QMS, GxP, Audits & Trainings |
Extensive Professional Research Experience and Achievements
With an extensive professional research experience [25 years], as Lead Trainer - WHO, Geneva; Manish, has trained over 250 GCP Inspectors of various Asian Regulatory Agencies (China, Thailand, Malaysia, Indonesia, Singapore, Philippines, Qatar) through WHO-PQT-Workshops; and over 1000 Clinical Research professionals including 500+ Bioanalytical & GLP Professionals, 400+ Clinical /GCP Professionals, 100+ Quality Professionals of CRO / Pharma Research and international regulatory organizations.
As Authorized Lead Trainer – NABL & GLP – JJM-CSE, and till date, trained over 500 Chemists / Lab personnel of Government Water testing Labs.
As Independent Auditor, successfully, conducted & concluded over 500 Audits / Monitoring/Review (USFDA-150+, EU/EMA-250+, WHO-50+, ASIA-100+).
Honors and Certifications
- Project Lead – Clinical Assay Group (CAG), Pfizer, US – Phase-I Bioanalysis (10+ Projects)
- Project Lead – Clinical Projects, Novartis, US – BA/BE/DDI studies (10+ Projects, 1 publication)
- Certified Operator & Trainer for HPLC, LC-MS/MS, LIMS, TOMTEC Robotics & Phoenix WinNonlin
- GBC Harmonization Team Member: A1–Scope & Regulations, A6 – Stability, A9 – AIQ
- Speaker, Organizer & Panelist: APA, CVG, JBF, CPhI, CSI, Waters, Thermo, & Universities.
Moreover, he has authored 50+ peer reviewed Research Articles published in reputed international journals and he has reviewed 50+ Manuscripts till date as Reviewer to JPBA, JCS, JCB, BM and JBB. Manish was considerably instrumental in advancing Bioanalysis and Industry-Academia interface in India and at global level as well. Manish is CEO & Founder, ETHIXINN Consulting & Research Solutions, India, and dynamically contributing to various international organizations (APA / JBF / CSI / CVG / Waters / Thermo) as Organizer / Speaker / Panelist or Board member; and delivered 50+ invited talks to national and international conferences.
He was Founding member & Key player in establishing and successfully running the;
- 2 CROs (GVKBIO-Hyderabad-2003 and VEEDA CR-Ahmedabad-2004)
- 3 Bioequivalence centers (Aurobindo R&D-Hyderabd-2002, Cadila Pharma-Ahmedabad-2010, Alkem Labs-Mumbai-2012)
- 9 Bioanalytical Labs (Torrent, Aurobindo, GVKBIO, Veeda=2 Labs, Cadila, Alkem=2 Labs & Scimagma Labs).
Successfully, faced 31+ international regulatory inspections – USFDA, MHRA, ANVISA, WHO and 500+ Clients audits. Also, privileged to execute the first LC-MS/MS experiment of bioanalytical lab of Aurobindo, GVKBIO and Veeda.
Manish has acquired his Masters in Analytical Instrumentation and Chemical Analysis from Jiwaji University, M.P., India, 1998 and presently pursuing his Ph.D. in Bioanalytical Chemistry from Jiwaji, India. During his 25 years of research voyage, Manish has worked for LAMBDA Therapeutics, TORRENT Research Centre, AUROBINDO Research Centre, GVKBIO, VEEDA CR, CADILACRO & ALKEM Labs Research Centre, and handled 500+ Molecules, 1000+ BA/BE/DDI studies, a few CTs and Phase I studies.
COMPANY exposed to: Pfizer-US, Novartis-US, Rosemont-UK, Key Pharma-UK, Aesculape-Belgium, Anfarm-Greece, Biopharm-Algeria, Novugen-KL, Hovid-KL, Pharmaniaga-KL, Malaysia, Dr. Reddy, Piramal, MSN, Apotex, SelectBio, BioTrains, Compliance Trainings, RegenixBio, Strides Arcolab, Naprod LS, Ajnata Pharma, Marksans, Lambda, Torrent, Aurobindo, GVKBIO, Veeda, Cadila, Alkem Labs, Axis, Cliantha, Nortrox, Vayam, Glocare, ClinSync, Raptim and Vimta.
Worked with REGULATORY AGENCY: USFDA, EMA, WHO, MHRA, ANVISA, CANADA, AGES, NABL & DCGI.
Worked with COUNTRIES: US, UK, Canada, Japan, Algeria, Greece, China, Thailand, Malaysia, Indonesia, Singapore, Philippines, Dubai, Qatar and India.
