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Raaj Global Pharma Regulatory Affairs Consultants Thane-mumbai profile-updated-2013


Raaj-GPRAC is a Thane-Mumbai (India) based agency. …

Raaj-GPRAC is a Thane-Mumbai (India) based agency.
Our offerings includes but not limited to making Regulatory filing strategy, Preparation of pharmaceutical product registration dossier, filing assistance, response to regulatory queries, life cycle management, regulatory compliance audit and Training.
We offer flexible and need based services to meet customer/client requirements so as to save time and cost.

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  • 1. Trust Our Experience to Manage Your Regulatory Submission Raaj Global Pharma Regulatory Affairs Consultants (Raaj GPRAC) © Raaj GPRAC 2011 © Raaj GPRAC 2011 © Raaj GPRAC 2011 1 1
  • 2. Rajashri Survase-Ojha Founder and Director of Raaj GPRAC A competent and achievement oriented professional with 20+ years of progressive experience in the BPO, KPO and pharmaceutical industry like Cognizant, Novartis-OTC, Glenmark , GSK-TCS, Sandoz, Famycare, local FDA and Unichem laboratories, since 1991. Excellent network of regulatory professionals, opinion leaders, regulators, policy makers and business leaders. Strategic knowhow on outsourcing and off-shoring in key emerging countries. Regulatory Affairs Expert in Formulations and API, QA-QM, CMC , Clinical and Pharmacovigilance. Experience in R and D, Analytical Dev, Formulation Dev; Technical Documentation etc. Worldwide Regulatory affairs and submissions expert as per country-specific requirements in formats like CTD, eCTD, ACTD, NeeS, etc.[USFDA, EMA, CANADA, UK-MHRA, SA, LATAM & RoW, INDIA] Expert in cGMP/GLP/GCP aspects, Audits & Inspections, Validations required in Pharma industry. Expert member of OMICS-US, UBM, Member of IPA, DIA, IDMA, RAPS, TOPRA, Global Compliance Panel(DE), Global Intelligence, FIP etc. Invited Speaker on Technical, Quality and Regulatory Affairs, Clinical related subjects at various National and International forums and Chaired many scientific sessions. © Raaj GPRAC 2011 2
  • 3. Rajashri Survase-Ojha Training is expensive. Without training it is more expensive. - Pandit Nehru  Trainer in Pharma Healthcare, Clinical, BPO, KPO and Pharma Colleges.  Undergone training on IMMS and Documentum at UK , GEMA, eCTD, Project Mgmt at Switzerland.  Adjunct Professor at JSS University in Mysore for ‘M.Pharm in Drug Regulatory Affairs’. © Raaj GPRAC 2011 3
  • 4. Who We Are? Our team has strong technical expertise to analyze and rapidly understand complex issues and to provide expert advice for our client’s business requirements. GMP Compliance , VALIDATIONS as per 21 CFR Parts, Audits & Inspections, Quality Assurance and Regulatory Affairs(RA) issues are critical to the success of any business, regardless of its size. We provide a comprehensive range of GMP, Validation, QA-QM, Documentation, Regulatory filings and its supported services from start-up till you get marketing Approvals. We are a specialized service provider in Regulatory Affairs for API/ Formulations for Regulated and Semi-regulated markets. We are a specialized TRAINER to provide effective training as per customerspecific requirements. Our objective is to provide effective commercial solutions to our client’s business while taking care of fitting those solutions within the legal framework. © Raaj GPRAC 2011 4
  • 5. Who We Are? Raaj GPRAC Technical team comprises of skilled professionals with core competencies that cover: • Pharmaceuticals/Life sciences/ Biotechnology/BPO/KPO • Medical devices/Cosmetics/Herbals • Global Regulatory Affair services in USFDA, EU, Canada, India, China, GCC, CIS, ASEAN and RoW (Rest of the World) • CTD/eCTD/ACTD/NeeS Submission Experts • DMF/ASMF/KDMF/COS-CEP Submission Experts • GMP/GLP/GCP, Compliance Experts • BA/BE Study Experts • Clinical Submission Experts • Audit-Inspection Experts • SoP, CMC, VALIDATION, GMP and Technical Documentation Experts © Raaj GPRAC 2011 5
  • 6. Company Profile Raaj Global Pharma Regulatory Affairs Consultants Raaj-GPRAC is a Thane-Mumbai (India) based agency. Our offerings includes but not limited to making Regulatory filing strategy, Preparation of pharmaceutical product registration dossier, filing assistance, response to regulatory queries, life cycle management, regulatory compliance audit and Training. We offer flexible and need based services to meet customer/client requirements so as to save time and cost. "We strongly believe in high quality work". © Raaj GPRAC 2011 6
  • 7. Our Vision and Mission VISION Establish global presence for providing full range of REGULATORY AFFAIRS & TRAINING Services to Pharma and Biotech industry. OUR MISSION The ultimate goal of Raaj GPRAC is to have its own identity in the Pharma industry as a most trusted service provider in all aspects and a one stop solution for high quality, time bound and cost effective Regulatory and Training services. Our mission is to provide our clients with the peace of mind that comes with being fully compliant with FDA rules and regulations for registration of Drug Substance and Drug products in CTD/eCTD/ACTD/NeeS formats. Raaj GPRAC is committed to maintain 100% client’s satisfaction. Our staff consists of seasoned professionals from the Regulated industry, whom are best able to interpret and comprehend complex and often ambiguous FDA, EMA, Health Canada, MHRA, TGA, MCC, ASEAN, and RoW requirements. © Raaj GPRAC 2011 7
  • 8. © Raaj GPRAC 2011 8
  • 9. What we can offer! Our Services Regulatory Consulting US/EU/ROW/ Canada/ Japan/CIS/ GCC etc. © Raaj GPRAC 2011 Domestic Product Registration DCGI/CDSCO/ State FDA Formulation ANDA/IND/ NDA/BLA ANDs/DCPs API Filings, DMF/CEP/ ASMF/ KDMF 9 Pharma Consultancy and Placement Industry Training Quality Audits, Inspections, Validations
  • 10. Our Services DRUG SUBSTANCE and DRUG PRODUCT • • • • • • • • • • • • Drug Firm Establishment Registration with USFDA (FEI No.) Drug Listing in SPL format, BULK DRUG Listing NDC no. and Electronic submission Preparation of DMF/ASMF/CEP or (CoS) eCTD preparation for EU , US Submission Regulatory filings of Generics IND/NDA/ANDA/BLA/ANDS etc. to US, Europe, Canada and Row market Dossier preparation and compilation as per Common technical dossier (CTD/eCTD/NeeS) format/ Asian Common Technical Dossier (ACTD) Guidelines / South Africa (MCC-MRF-1) Guidelines/ Brazil ANVISA Guidelines. Critical Review of Dossier and Preparation of GAP Analysis Report CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Manufacturing Formula and Process etc. Consulting and preparation of all five modules (M-1, M-2, M-3, M-4, M-5) for registration purpose in any country. Re-formatting old Dossier/DMF, NTA to CTD/eCTD format. © Raaj GPRAC 2011 10
  • 11. What we can offer? AUDITS and TRAINING • Regulatory Compliance Audits, VALIDATIONS and ISO Certification • Support in Successful AUDIT Preparation for WHO-GMP, USFDA, UK-MHRA , EdQM , ANVISA & others. • Support in DCGI & FDA activities • Support in Clinical Submissions • Support in Outsourcing Manufacturing or Testing Laboratories for Clients • Support in Outsourcing BA/BE study centres • Training and Workshops on RA/QA/AD/FD/ICH/CTD/eCTD/ACTD/21CFR parts/ GMP/GLP/GCP/Clinical etc. with Case studies, Exercises, Questionnaires • Guidance and Counselling of Pharma students • Training and Development of Pharmacists, RA/QA/Clinical Associates • Pharma Placement Services • Resume Development & Interview techniques for RA/QA/Clinical professionals. • Grooming and Mentoring future leaders in Pharma RA/QA/R & D/Clinical field. We can also travel to your location, R & D, Production sites, Regulatory affairs/ Corporate office, Colleges/Institute etc. to provide focused training(2 to 3 days) in various aspects of Regulatory Affairs, Technical Documentation, GMP/GLP, VALIDATION, Compliance etc. as per the need basis. © Raaj GPRAC 2011 11
  • 12. OUR PRODUCT –Ready to sell More than 1000 Global Model Templates as per ICH and Country-specific Requirements. This includes all CTD/eCTD Modules (M-1, M-2, M-3, M-4 & M-5), ACTD templates as per Asian requirements(Part I,II,III,IV), MRF-1 templates as per South Africa etc, We design Model templates as per country-specific requirements across the GLOBE. Analytical related Documentation, Method Validation, Formulation Development, Manufacturing formula/Manufacturing Process, BMR, BPR, Stability Protocols/Reports, Flow-Charts, PDR as per ICH Q-8, QOS, Expert Reports, Clinical protocols, etc. More than 1000 SOP’s: This provides standard operating procedure for operating, maintaining, cleaning of all the equipments/vessels/utilities. In addition it covers SOPs for Quality control, Change Control, CAPA, QC/QA, QMS, Internal Audits, Regulatory Affairs, OOS, facility design, house keeping, hazards control etc… All types of GMP/GLP SoP's required to set up a new lab or R & D or Manufacturing units of Solid, Liquid oral dosage forms. TRAINING MODULES ALONG WITH STUDY MATERIAL on Diferent Types of Courses. © Raaj GPRAC 2011 12
  • 13. OUR PRODUCT- Country-Specific Templates COUNTRIES HANDLED • USFDA, HealthCanada (Submissions in CTD/eCTD format ) • EMA –EdQM (Submissions in CTD/eCTD/NeeS format ) • UK-MHRA, Australian-TGA (CTD formats) • ASEAN Countries (ACTD format) • South Africa (MCC:MRF-1 format and CTD) • LATAM (e.g. Brazil, Mexico Submissions in CTD format) • GCC, UAE, African countries, • Russia(CIS), Ukrain, Kenya • SwissMedic (Switzerland) • RoW= Rest of the World (Submissions as per each Country-Specific requirements) • WHO, India, China, etc. © Raaj GPRAC 2011 13
  • 14. Our Customers Technical support, provided for the Dossier preparation and submission of DMF, KDMF and Dossiers/ANDA/ANDs in CTD/eCTD /NeeS/ACTD formats to Regulated and Semi-Regulated markets. Trainings, Audits and Compliance Support to their employees. • • • • • • • • • • • • • • © Raaj GPRAC 2011 • • • • • • • • • • • • • • Sandoz, Novartis Cipla, Alembic Fredun, Troikaa, Syncom Formulations, Venus Remedies Titan Labs, Mehta API Genom Biotech Rockdale HealthCare PellTech Healthcare SCOPE Ingredients VetoQuinol Incepta Pharma, Dhaka Zenta 14 Famy Care Ltd Profam HealthCare, Alves Healthcare, Solco Healthcare, Galpha Laboratories, REPL, Meha Chemicals Cognizant, TCS, ATOS, Accenture Kamani Oils Piramal Healthcare Sonal Plasrub Apoorva International Naturmega C.S. Teva pharma, etc.
  • 15. OUR ACHIEVEMENTS • ANDA submitted to USFDA - 28 for Drugs Products + 3 Hormonal products and 3 NDA(New Drug Application) to Europe and US. • ANDs submitted to HealthCanada- 3 Drug Products and 2 Hormonal products. Regulatory submission to • MHRA - 25 Drugs Products. • EU for MA - 15 Drugs Products, 25 Variations Type-I, II • WHO - 180 Drugs Products. • MCC S.A. –15 Drugs Products. • ASEAN Countries in ACTD – 120 Drugs Products. • RoW Countries – more than 500. • 5-DMF submitted of Type II, and 3 DMF of Type IV • 2 KDMF (Korean) • Well acquainted with USFDA, EMA, EdQM, MCC, TGA, 21CFR, ICH Q1, Q2…. to Q-10, Q-11 requirements. • TRAINED more than 2500 students and RA/QA/Clinical Professionals across the GLOBE. • AUDIT FACED: USFDA, EdQM, UK-MHRA, WHO, ANVISA, Local FDA, Different HA etc… © Raaj GPRAC 2011 15
  • 16. Training & Education Best-in-Class Content, First-rate instructors/Trainers and quality content highlight Raaj GPRAC best-in-class and distance learning program. Our instructor-led courses, in-company training, certificate programs, and distance learning and online training offer a variety of courses in Regulatory affairs, CTD/eCTD, Quality Assurance & Quality Management, Clinical Research, Pharmaceutical Documentation, Pharmacovigilance and much more. We Design and Provide different training Modules as per the Customer specific requirements. FAST TRACK PROGRAMMES for 2days, 3-5days, 1wk, 2wk, 1m etc…based on the TOPIC of YOUR CHOICE. © Raaj GPRAC 2011 16
  • 17. Achievements 2010-2012 Industrial training and Certificate COURSES Offered as follows PG Diploma RA in Formulation (6m) PG Diploma RA in API(6m) CTD/eCTD in FP/API(4m) PG Diploma in QA-QM(3m) PG Diploma in Clinical Research(3m) PG Diploma in Pharma Documentation(3m) PG Diploma in Pharmacovigilance(3m) PG Diploma in Patents Law & Procedures(6m) © Raaj GPRAC 2011 17
  • 18. Achievements 2010-2012 May-2010 - Incorporation of ‘’Raaj GPRAC’’ training Center at Thane-Mumbai. INAUGURATION BY Mr. K.ANAND( President, Zydus Cadila, COO-FAMY CARE LTD.) Provided services and training to Pharma industry & CRO’s for Dossier filing, Regulatory Compliance Audits e.g. Famycare, Alves Healthcare, Syncom Formulations, Makrocare, Profam Healthcare, Genom Biotech etc. July2010- December2010 Launched Class-room training programmes & Distance Learning programs on PG Diploma in RA (Formulation/API) and CTD/eCTD in Formulation/API., QA-QM, Pharma Documentation, PV etc. © Raaj GPRAC 2011 18
  • 19. Achievements 2010-2012 8th March 2011 One day Workshop on 'Scientific Technical Writing' at HK college of Pharmacy. Approx. 275 Students and teaching staff, Professors benefited out of it. Distance Learning New course Launched on 4m Certification course in Clinical Research 12th May-2011 One day interactive Workshop on 'Regulatory Affairs and Effective Scientific/CMC writing and review skills' organized at KLE college of Pharmacy, Belgaon on 12th MAy-2011 where approx. 120 students, Professor and pharmacy staff have taken advantage of it. © Raaj GPRAC 2011 19
  • 20. Achievements 2010-2012 9th & 10th JULY 2011 Raaj GPRAC nobly announce successful completion of 2days seminar in Mumbai on 9th and 10th July2011 on “Core Concepts of e-CTD” at Jogeshwari .This training was designed to serve current industry needs concerned with electronic filings. Delegate from Alembic, Sun Pharma, Lupin, Unichem, Cipla, Piramal Healthcare, Elder Pharma, Indoco Remedies, Cognizant, Fortis labs, Vetoquinol, Sidvim, Kamani Oils, Titan labs & Freshers B.Pharm/M.Pharm etc © Raaj GPRAC 2011 20
  • 21. Achievements 2011-2012 6th August- 2011 Raaj GPRAC concludes Seminar on "Pharma Career Counseling" in Thane- Mumbai on 6th August 2011 This Programme was inaugurated By Dr Suhasini Bhalerao, Principal , Hiranandani College, Ulhasnagar with an inaugural Speech. The speech was followed by Book release of "RAAJ GPRAC GUIDE TO THE PILGIRMAGE TOWARDS PHARMACY PROFESSION" by Bhalerao. This book highlights the knowledge of global requirements for Pharma industry , Career in Pharmacy, Regulatory Affairs and clinical research etc. This Seminar was delivered in 2 sessions the first session was addressed by Rajashri Ojha who spoke on Pharma current industry scenario, understanding the opportunities available in Pharma industry, importance of pharmacy profession, Regulatory Affairs profession and role of different departments. The second session was addressed by Mamta Gandhi, Pharma expert , who talked on each sector in Pharma industry and how do they work, organizational behavior in industry , understanding the difference between professional and academic career. © Raaj GPRAC 2011 21
  • 22. Achievements 2011-2012 3rd – 8th September 2011 FIP World Congress of Pharmacy and Pharmaceutical Sciences 2011 Ms. Rajashri Ojha attended the 71st Internatonal Congress of FIP, held from 3rd Sept- 8th Sept 2011 in Hyderabad , INDIA. Dr. B.Suresh (President, PCI) Pratibhatai Patil, President of India © Raaj GPRAC 2011 22
  • 23. Achievements 2011-2012 24 September 2011 Raaj GPRAC Successfully executed Workshop on "CTD Concepts & Effective CMC writing-review skills" in Thane- Mumbai on 24th September 2011 To say that this event was a spectacular success is an understatement. The speaker, Rajashri Ojha regaled the audience as much with her wit and liveliness as by her total command over the topics on which she talked. She Covered techniques on Scientific writing and CMC writingReview skills with the CASE-Studies. Shared thorough knowledge of the CTD requirements of Technical Documentation, understanding of the requirements for each module of the Common Technical Document (CTD), to be used for IND/NDA/ANDA/ANDS submission and International document standards. 29th- 30th September 2011 Raaj GPRAC in collaboration with JSS College of Pharmacy,Mysore Conducted 2 day interactive Workshop on "Organization of CTD and CMC- Writing & Review Skills" on 29th -30th Sept 2011, where more than 250 students, Professor and pharmacy staff have taken advantage of it. © Raaj GPRAC 2011 23
  • 24. Achievements 2011-2012 October – 2011 Distance Learning New course Launched of 3m Certification Course in Pharmacovigilance 4th – 7th November - 2011 Emerging Challenges and Issues in Higher Education Ms.Rajashri Ojha attended 3 days international conference at Jaipur on "Emerging Challenges and Issues in Higher Education" from 4th Nov - 7th Nov 22nd- 24th November - 2011 GMP, Audits and Inspection as per Regulatory Requirements for Sonal Plasrub India ltd. Raaj GPRAC Successfully accomplished with 3 days training on GMP and audit- inspection on 22nd- 23rd24th November 2011. © Raaj GPRAC 2011 24
  • 25. Achievements 2011-2012 26th & 27th November - 2011 National Conference on governance in Healthcare by 2020 Ms.Rajashri Ojha attended 2 days "National Conference on governance in Healthcare by 2020" in Indian Institute of health management research on 26th and 27th November . Ms. Rajashri Ojha was also selected for Poster Presentation on the topic - Regulating and reforming the Pharma curriculum in India at this Conference 9th & 10th Dec- 2011 Raaj GPRAC concludes Seminar on "Core Concept of eCTD with Live Demonstration" which was held at Hotel Satkar Residency, Thane on 9th and 10th Dec 2011. This event was a spectacular success with the four eminent speakers- Rajashri Ojha, Geetanjali Jaguste , Hrushikesh & Jayprakash Nallaswami (Live Demo). The participants were amazed and enjoyed all the sessions along with Live eCTD-DEMO from LORENZ on which the seminar was hosted. The response we received gives us the confidence to say with aplomb that you can expect a lot from us in the future.. © Raaj GPRAC 2011 25
  • 26. Achievements 2010-2012 January 2012 Raaj GPRAC brought about the workshop on “sailing through the critical phases of Audits and inspections" which was held at Hotel Satkar Residency, Thane on 7th and 8th Jan 2012. This event was a great success with the four renowned speakers- Mrs.Rajashri Ojha, Mr.Santosh Savarkar , Dr.Nandkumar Bhilare and Dr.C.R.Deo. The participants were all astounded and took pleasure in all the sessions. © Raaj GPRAC 2011 26
  • 27. Article Writing, Reviewing and Publishing Skills "on 21st Jan 2012 at Hotel Satkar Residency-Thane © Raaj GPRAC 2011 27
  • 28. BANGKOK-2 Days Workshop on “Organization of CTD, eCTD and ACTD and Effective CMC-Writing, Review skills“ held on 26th - 27th Jan 2012 at Hotel Golden Tulip- BANGKOK,Thailand Company: Incepta Pharma, Dhaka © Raaj GPRAC 2011 28
  • 29. 2 Days Workshop on “Organization of CTD, eCTD and ACTD and Effective CMC-Writing, Review skills“ held on 26th - 27th Jan 2012 at Hotel Golden Tulip- BANGKOK,Thailand Company: Incepta Pharma, Dhaka © Raaj GPRAC 2011 29
  • 30. 2 Days Seminar on “VALIDATIONS and 21 CFR Part 11 Computer System Validation “ DATE: 27th - 28th April 2012 at VENUE: Hotel Satkar Residency, Thane-Mumbai © Raaj GPRAC 2011 30
  • 31. Two Days Workshop on GMP and Worldwide Regulatory Submission Requirements DATE: 13th - 14th JULY 2012 VENUE: HOTEL BALWAS INTERNATIONAL, INDORE, MP. © Raaj GPRAC 2011 31
  • 32. Certificate Distribution Heartily Congratulations! © Raaj GPRAC 2011 32
  • 33. Competitive Intelligence (CI) Technical Evaluation of Documents, Systems, Design, Qualification, Va lidations etc. Advising on Cost and Time saving Regulatory Strategies and to get faster approvals Market Research, TRAINING as per customerspecific requirements across the Globe. Finding Customers for API and Product manufacturing, Testing Laboratories, BA/BE study centers and all outsourcing activities etc. Strategic Planning Prior to Regulatory Submission © Raaj GPRAC 2011 33
  • 34. Raaj GPRAC Advantage VALIDATION Quality Compliance Regulatory Expertise, CTD/eCTD/ ACTD experts Effective Training Methodology Customer Satisfaction Data Security 21 CFR Part 11 Compliance Regulatory Strategy Research Tools Confidentiality © Raaj GPRAC 2011 34 Success!!!!
  • 35. TESTIMONIAL Dear Mrs. Rajashri Madam, The 2days Validation Workshop was very informative and interactive. All speaker was very good, personally I get a lot of information, specially I could say it was innovative as they put the new concept instead of wasting time for traditional information. Though there was people from all streams (production, engineering, Quality, Electronic, Research), all speaker maintained the balance between the basic information and latest information. Thanks for such Nice, Informative work shop. These will definitely help me in day to day and future work. Thanks. Kedar Prasad, Manager-Sandoz “It is with great pride and pleasure that I recommend my friend (Ms. Rajashri) as a great human being and team player. I have known her for over 10 years now. She has a very cheerful disposition and I have seen her handle even the most stressful of situations with a smile on her face. Her positive attitude, enthusiasm and vivacious nature have always made a great difference to everybody around her. I wish her all the best in life.” Rajesh Parab, Technical Manager, Colorcon “Rajashri is an extremely devoted, motivated person who is ready to take new challenges. Few qualities that I associate Rajashri with are Attention to detail, Very thorough and methodical in the task she takes up and always ready to help. She was extremely patient with me in teaching me the basics of quality management. I am extremely thankful to her for taking a keen interest in developing my professional skills. I wish her all the very best in all her future endeavours.” Hemant Pachnanda, Director, Business Development & Strategy at Sanofi-Aventis © Raaj GPRAC 2011 35
  • 36. TESTIMONIAL Thanks for the wonderfully organized Workshop which was very informative & was also rich in content due to the high quality of Speakers & their vast experience. I also take this opportunity to wish you & your dedicated team all the best for future such endeavors from Raaj GPRAC. With regards, Dr.Nagesh Sandu, MD-Sandu Brothers Attending the training course was indeed a pleasure and an eye opener for us. We thank you for the knowledge imparted to us. Manish Purecha, MD-Sonal Plasrub Pvt.Ltd. Dear Madam, We are also here conveying gratitude for arranging very viable topics with rich experienced person with very reasonable fees. Chandrakant.B.Patil, Manager QA. Embio Limited. “I have had several interactions with Rajashri and am particularly amazed by her dedication and hard working attitude. Her attention to details is something to look up to and her friendly nature enables having a comfort zone while coordinating with her.” Asheesh Bhimsaria, Commercial Manager, Pharmalink Consulting The Raaj GPRAC Institute is a great initiative by Mrs. Rajashri Ojha madam for professionals who are working in the Pharma Industry and for experienced professionals who are looking out for a change over. The eminent guest faculties shared their rich experience with us during the course and helped us to improve technical expertise. This course has helped me a lot to gain knowledge about registration procedures. Wishing you all the very best in your future endeavors. Santosh Pedamkar, QA- Ass. Manager - EthyPharm Pvt. Ltd. © Raaj GPRAC 2011 36
  • 37. TESTIMONIAL To begin with, I am and will always be indebted to Mrs Rajashri survase-ojha that she made me be acquainted with the exciting world of drug regulatory affairs which is going to give my pharmacy career a new lease of life. So on this occasion I take the opportunity to thank her and the entire team of Raaj GPRAC from the bottom of my heart. She has been very co-operative and informative since I was on the verge of thinking about this course. Of particular interest is her realistic personality. Having procured an experience of a great many years she has carved a niche for herself in the pharmaceutical sector. So far as the course of drug regulatory affairs is concerned, I have developed strong understanding of every attributes of regulatory domain. All other courses and training sessions have designed in such an approach as if we work in industry. Besides, lectures given by renowned and expert guests have unquestionably helped all students get an insight into the regulatory environment. In the long run, the overall experience at Raaj GPRAC has been quite interesting and enlightening for which the credit goes to our respectful Rajashri madam and her whole team. I wish Raaj GPRAC all success in their future endeavours. Many thanks. ONKAR DESHMUKH [The UNIVERSITY OF GREENWICH, UNITED KINGDOM.] I would like to express my sincere thanks to the Raaj GPRAC Institute for their efforts taken during the time span of course. Courses offered by Raaj GPRAC are really advanced. The lectures were very interactive and provide the knowledge of current norms of the industry. Faculties were very good and were always ready to give thorough knowledge about the subject. The guest faculties shared their rich experience with us during the course and helped us to improve technical Knowledge. The course has helped me to gain knowledge about regulatory filing in many of the countries such as US, EU and RoW in this 6 month course duration. Again I would like to thank Institute and Mrs. Rajashri Ojha for their help and support during the course and all the best for future! Ankush Patil (M.S. Formulation Science, University of Greenwich, UK) I would like to thank Mrs. Rajashri madam & her entire team of RAAJ GPRAC. I opted for Distance learning program and they have always helped me getting my queries cleared regarding the course in drug regulatory affairs.The study material designed by RAAJ GPRAC will definitely prove very valuable for those who want to get their foot in the regulatory door. I wish Mrs. Rajashri Ojha & her entire team every success for future. Kalpesh Patil, QC-Officer- Arch Pharmalabs Ltd. © Raaj GPRAC 2011 37
  • 38. TESTIMONIAL Raaj GPRAC is an excellent institute for post graduate diploma in Regulatory affairs for formulation, API , and Quality Assurance & Quality Management with many other courses like Clinical Research, Pharmaceutical Documentation and CTD/eCTD. They conduct lot of Complementary Lectures apart from Study materials For Student’s Personality Development , technical writing-review skills, etc.. The Lectures were conducted by Mrs. Rajashri Ojha and many Guest speakers from industries who are the subject expertise and I found all sessions very interactive and knowledgeable. I have experienced very grateful moments in Raaj GPRAC and have learned a lot which will be useful for me for the rest of my life. Raaj GPRAC institute is very supportive to students about notes, extra knowledge and job assistance/placement also. I am very much thankful to RAAJ GPRAC and give my best wishes for its Success. Vishal G. Jagtap ( Quality assurance Flamingopharma ) I have no words for RAAJ GLOBAL PHARMA and This institute is one of the best institute in Mumbai for those who want to go in regulatory area. Mrs Rajashri Ojha is one of the eminent trainer who really help and support the students from the bottom of the heart. In those 6 month I learnt lot from madam about the practical approach in the field of regulatory profession. I equally thankful to team for providing study materials and for conducting online exams. I request all the students and industrialist to join Rajashri Madam group to understand the every expect of Pharma Regulatory. Once again thanks to all the members of Rajglobal pharma. Dr. Ankur Jain © Raaj GPRAC 2011 38
  • 39. Our Publications 1. Paper Presented at International pharmanext conference at Goa on the topic ‘’Evaluation of Training required for Registration of Pharmaceutical Products in Regulated and Semi-Regulated Markets’’ 2. Paper Presentation at National conference on the topic ‘’Clinical Trial in India: Current Regulatory and Ethical Overview’’ 3. Article Published on ‘Medical Devices, Need Attention’ in Express Pharma Pulse issue May1-15, 2011 4. Article Published on ‘Importance of Regulatory Affairs’ in Express Pharma Pulse issue June1-15, 2011 5. Article Published on ‘Call for harmonization of Regulatory system across the GLOBE’ in Express Pharma Pulse FIP-2011 issue Sept-1-15 6. Article Published on ‘Herbal Pharmacovigilance-India Vs Global Outlook’ in Express Pharma Pulse IPC-2011 issue Dec-16-31 7. Abstract on "Emerging Challenges and Issues in Higher Education" from 4th Nov - 7th Nov Conference at Jaipur 8. Research Paper published in International journal of SAJMMR-Feb-2012 on ‘REGULATING AND REFORMING THE PHARMA CURRICULUM IN INDIA’ 9. Book released on "RAAJ GPRAC GUIDE TO THE PILGIRMAGE TOWARDS PHARMACY PROFESSION’ 10.OMICS; 2nd International Conference and Exhibition on 'Pharmaceutical Regulatory Affairs' November 2324, 2012 Hyderabad International Convention Centre, India,Pharma-2012. Abstract no. 1237:-‘Emerging issues & challenges in pharma education and Training system: An overview’ 11.OMICS Abstract no. 1238:-‘Regulating the pharmacist: A change for the better’ 12.OMICS Abstract no. 1239:-‘Managing talent and performance in pharma industry: Key to global successes’. 13.Article Published on ‘Regulatory Intelligence-Need of the Hour’ in AJPRD Vol1(2) Mar-Apr 2013 14.Research Article Published on ‘The Necessity of 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’ in IJPCS Vol2(2) Apr-Jun 2013, 1135-1143 © Raaj GPRAC 2011 39
  • 40. Our Publications © Raaj GPRAC 2011 40
  • 41. Corporate Office 303-VITTORIA, Hiranandani Estate, Patlipada, G.B.Road, Thane- (W) Pin-400607 TRAINING CENTER 144, Boulevard, Premium Shopping, Lodha Paradise, Nr. Nasik Eastern Express Highway, Majiwada, Thane -west, Pin-400601 Email us at: Contacts: 9821144706/ 022 65619030/40127947 © Raaj GPRAC 2011 41
  • 42. © Raaj GPRAC 2011 42