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.

1. Trust Our Experience to Manage Your Regulatory Submission
Raaj Global Pharma
Regulatory Affairs
Consultants
(Raaj GPRAC)
www.rajgprac.com
© Raaj GPRAC 2011
© Raaj GPRAC 2011
© Raaj GPRAC 2011
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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
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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
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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
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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
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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
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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
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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
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Pharma
Consultancy
and
Placement
Industry
Training
Quality
Audits,
Inspections,
Validations

10. Our Services
DRUG SUBSTANCE and DRUG PRODUCT
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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
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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
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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
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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
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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.
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© Raaj GPRAC 2011
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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27. Article Writing, Reviewing and Publishing Skills "on 21st Jan 2012 at Hotel Satkar
Residency-Thane
© Raaj GPRAC 2011
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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
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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
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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
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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
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32. Certificate Distribution
Heartily Congratulations!
© Raaj GPRAC 2011
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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
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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
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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
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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
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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
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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
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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
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40. Our Publications
© Raaj GPRAC 2011
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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:
raajglobal1@gmail.com
info@raajgprac.com
raajgprac@gmail.com
Contacts: 9821144706/
022 65619030/40127947
© Raaj GPRAC 2011
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42. www.rajgprac.com
© Raaj GPRAC 2011
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