- Mrs. Rajashri Survase-Ojha is GMP and LEAD AUDITOR-13485[QMS- Medical Devises]
She is a senior RA professional, GMP consultant and Auditor and has over 27+ years of very versatile experience in pharmaceutical/Biotech industry, starting her career FROM Scientist in R & D, Analytical & Formulation, QA-QM, till GLOBAL regulatory Affairs. Expertise in getting marketing approvals of Generics, DRUG SUBSTANCE/DRUG PRODUCTS/MEDICAL DEVICES/OTC/ Neutraceuticals & FOOD across the Globe.
Rajashri is the founder and Managing Director of Raaj GPRACPVT. LTD. [‘Raaj Global Pharma Regulatory Affairs Consultants] Thane-Mumbai since 2010 and completed 10 successful years as women Entrepreneurship. Raaj GPRAC is an ISO29990-2010 certified institute.
She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.
Awarded for WIB-2019 by Indo Global Chambers of commerce on 7th April2019 at Indore.
--She brings with her more than 27+ years of rich experience working for leading organizations like SPECTRUM Pharmatech, SYNERGY PHARMA UAE, Raaj GPRAC, COGNIZANT , FAMYCARE , NOVARTIS, GSK-TCS, GLENMARK, SANDOZ, Ciba-Geigy, UNICHEM Labs, and LOCAL FDA, Bandra.
She is RAPS qualified and also hold PG Diploma in Intellectual Property rights (IPR), Pharma Quality Management and is a Regulatory Submission expert of CTD/eCTD/ACTD/NeeS formats. She has TRAIN the TRAINER, Six Sigma Green belt, 7 habits of most effective people and Cornerstone leadership certifications.
-She has published more than 18 Articles and Research papers in reputed journals.
-She has Trained more than 8500 candidates till now on various aspects of GLOBAL Regulatory Affairs, GMP, GLP, GCP, GDP, Country-specific Regulatory Submissions(USFDA, EMA, ROW, ANVISA, WHO, ASEAN, SFDA, CDSCO-DCGI & Others),
Quality Assurance & COMPLIANCE, 21CFR PARTS, GAMP-5, CSV, Clinical Research, Pharmacovigilance, Patents, Pharma Documentation and Pharma Management etc in Pharma & Biotech industry.
-Hands on expertise in Regulatory Affairs(RA) and ‘Regulatory Intelligence’(RI) and setting up of new business process and operations of ‘Regulatory Affairs’ and ‘Regulatory Information Management (RIM)’ and Training centers across the globe.
-Competent, diligent & result oriented professional experienced in Strategic Management, New Organizational Set-ups, Project Management, Resource Management, Compliance Management , Regulatory Submission Management across the globe.
-Significant experience in Registration, Liasoning and marketing Approvals of pharmaceutical Drug substance and Drug Products. -Handled submissions of DMF, KDMF, ASMF, CEP/CoS and IND/NDA/ANDA/ANDs to different National & International Health Authorities. Supported Regulatory Audits for USFDA, UK-MHRA, EdQM, ANVISA, TGA, SFDA, TFDA, MHLW/PMDA, WHO and other local Health Authorities.
-She is also associated with many leading education institutes/colleges in India as a ‘Guest faculty’.
-She is a Visiting faculty (Adjunct Professor)at JSS University in Mysore for ‘M.Pharm in Drug Regulatory Affairs’. ICT-UDCT, BCP, KLE, MET, NIPER, Sinhagad institutes, Bharati Vidyapith, Gehlot, HKCP, OCP etc.
- She is a member of IPA, DIA, IDMA, RAPS, TOPRA, OMICS, FIP, UBM, Global Compliance Panel, IMS, IBC etc. and Chaired many scientific sessions organized for National and International Conferences. ASQ Member ID: 65583963
- Received a Sandoz award for Excellence in December 2004 for the Best Individual Contribution
- Received a Best team support award for ANDA filings in Sandoz.
- Received many Token of Appreciation from various Pharma colleges and Institutes from all over India.
- She was awarded for ‘’ Women's leadership India Awards in Pharma Coaching ‘ by iiGlobal in February2017.
- LEAD AUDITOR-13485[QMS- Medical Devises]
- Six Sigma Green Belt trained
- ‘Train the Trainer’ Certifications
- Hands on eCTD certification
- PG Diploma in Patents, Quality Assurance and QM
- Certification in Cornerstone Leadership program designed for Sr. Managers in Hyderabad
- ISO 29990-2010
- LSSSDC Accreditation
- Paper Presented at International Pharmanext conference at Goa on ‘Evaluation of Training required for Registration of Pharmaceutical Products in Regulated and Semi-Regulated Markets
- Paper Presentation at National conference on the topic Clinical Trial in India: Current Regulatory and Ethical Overview
- Article Published on Medical Devices, Need Attention in Express Pharma Pulse issue May1-15, 2011
- Article Published on Importance of Regulatory Affairs in Express Pharma Pulse issue June1-15, 2011
- Article Published on Call for harmonization of Regulatory system across the GLOBE in Express Pharma Pulse FIP-2011 issue Sept-1-15
- Article Published on Herbal Pharmacovigilance-India Vs Global Outlook in Express Pharma Pulse IPC-2011 issue Dec-16-31
- Abstract on Emerging Challenges and Issues in Higher Education from 4th Nov – 7th Nov Conference at Jaipur
- Research Paper published in International journal of SAJMMR-Feb-2012 on Regulating and reforming the Pharma Curriculum in India
- Book released on “RAAJ GPRAC GUIDE TO THE PILGIRMAGE TOWARDS PHARMACY PROFESSION”
- OMICS; 2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs November 23-24, 2012 Hyderabad International Convention Centre, India, Pharma-2012. Abstract no. 1237:- Emerging issues & challenges in Pharma education and Training system: An overview
- OMICS Abstract no. 1238:- Regulating the pharmacist: A change for the better
- OMICS Abstract no. 1239:- Managing talent and performance in Pharma industry: Key to global successes
- Regulatory Intelligence : Need of the hour; Published by AJPRD in April-2013
- Research paper published by IJPRC in May-2013 on Evaluation of Training that calls for the Development of the Technical knowledge and Skills required for fresheres and associates working in different departments of pharmaceutical industry