We are one of the leading Regulatory Affairs and Quality Management Service Providers and Consultants of India since 2008 with focus on Quality. We have rich and varied experience of extending support to pharmaceutical industries for GMP, Regulatory and Quality Compliance. Customer satisfaction is our guiding force. We aim at aligning our process with the needs of the customer. So that all we do revolves around what our customer’s needs are. No wonder, satisfied customers are our biggest strength. Our process driven approach helps us deliver what we promise. And foster the trust the name Sai Pharma Solutions evoke. Our Motto: “Start to finish, everything in between”

1. INSIGHT OF OUR QUALITY MANAGEMENT , REGULATORY AFFAIRS AND GMP
CONSULTING SERVICES
By:
J.Ramniwas(M.Sc , M.Phil –Medicinal Chemistry)
Founder and CEO
Sai Pharma Solutions Inc, Vadodara(India)Sai Pharma Solutions Inc, Vadodara(India)

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Gateway to Global compliance with a promise
We are one of the leading Regulatory Affairs and Quality Management
Service Providers and Consultants of India since 2008 with focus on Quality.
We have rich and varied experience of extending support to pharmaceutical
industries for GMP, Regulatory and Quality Compliance. Customer
satisfaction is our guiding force. We aim at aligning our process with the
needs of the customer. So that all we do revolves around what our
customer’s needs are. No wonder, satisfied customers are our biggest
strength. Our process driven approach helps us deliver what we promise.
And foster the trust the name Sai Pharma Solutions evoke.
Our Motto: “Start to finish, everything in between”

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• Name: J.Ramniwas(International Speaker,Writer,Auditor and Technical, Scientific and Regulatory Affairs Advisor)
• Qualification(s): M.Sc, M.Phil(Medicinal Chemistry)
• Mr. J.Ramniwas has total more than 22 years of experience in various
Pharmaceutical industries as Global Quality Management and Regulatory
Affairs Professional.
• Mr.J.Ramniwas is the founder and Chief Executive Officer at Sai Pharma
Solutions Inc. headquartered in Vadodara, India
• He has been responsible for GMP compliance, Regulatory Affairs and
Quality Management Compliance services to various clients of Sai Pharma
Solutions Inc.
• He has held various management positions in many pharmaceutical
organizations such as Lupin Limited, Zandu, Zydus Cadila Healthcare
Limited, Tonira Pharma Limited and Tonira Chemical Company Limited,
Titan Laboratories Pvt Limited.
Global Quality Management and Regulatory Affairs
Professional Profile -1

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• His experience includes Regulatory Affairs, Analytical Development,
Analytical Validations, Quality Control, Quality Assurance, Development and
Establishment of Quality Systems, GMP and Regulatory Affairs trainings,
Qualifications and Validations of Facilities, Equipments and Utilities, GMP
Documentation, Auditing, Regulatory Submissions, Hosting customer and
Regulatory Audits, Risk Management and Compliance to Global Regulatory
Requirements
• Mr. J.Ramniwas has extensive experience of working with international
regulatory agencies, international associations such as USFDA, Health
Canada, EDQM, Korean FDA, ISO, MHLW, Japan and DIA,WHO etc. and
multinational customers such as Sandoz, TEVA, Polpharma, Almiral,
Astellas Torii, Nippon, Apotex, Corepharma Actavis, Takeda and Daichi
Sankyo etc.
Global Quality Management and Regulatory Affairs
Professional Profile -2

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• He is a member of Drug Information Association (DIA), Indian
Pharmaceutical Association
• He is also making contribution for writing articles on burning issues in
pharmaceuticals and his articles have been published by the Express
Pharma Pulse, Pharma Times, Pharma Bio World, Pharma Guide and in-tech
journal
• J.Ramniwas is representing India as a speaker and trainer for international
seminars on GMP, Regulatory Affairs and Quality Management Programs
conducted by IBC (Asia),Asia Business Forum, Malaysia, Singapore, Hong
Kong and Thailand, Global Regulatory Summits organized by CPhI etc.
Global Quality Management and Regulatory Affairs
Professional Profile -3

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Sai Pharma Solutions Inc is a boutique consultancy to
the pharmaceutical industries dealing in
1. API Manufacturing
2. Drug Product Manufacturing
3. Cosmetic Manufacturing
4. Ayurvedic and Herbal Product Manufacturing
5. Biological/ Biotechnological Product Manufacturing
6. Medical device manufacturing
We consult and train on Regulatory , GMP , Quality compliance,
Drug registration, validation, qualification and continuous
improvement of manufacturing process.
IntroductionIntroduction

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PreparingPreparing PharmaceuticalPharmaceutical Industries/InstitutesIndustries/Institutes forfor GlobalGlobal
RegulatoryRegulatory ComplianceCompliance byby education,education, training,training, auditing,auditing,
documentationdocumentation andand regulatoryregulatory submissionssubmissions byby wayway ofof generatinggenerating
awarenessawareness amongamong thethe pharmaceuticalpharmaceutical entrepreneursentrepreneurs regardingregarding
thethe futurefuture coursecourse ofof thethe regulatoryregulatory mechanismmechanism andand increasingincreasing
customer'scustomer's expectationsexpectations consequentialconsequential technicaltechnical upgradationupgradation forfor
pharmaceuticalpharmaceutical manufacturingmanufacturing facilitiesfacilities..
Our Vision

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1. MakingMaking PharmaceuticalPharmaceutical Industries/Industries/ InstitutesInstitutes appreciateappreciate thethe needneed toto changechange andand
prepareprepare aa systematicsystematic actionaction planplan forfor reviewingreviewing “Manufacturing“Manufacturing ActivitiesActivities andand
QualityQuality Systems”Systems” visvis--aa--visvis traditionaltraditional approachapproach ofof prioritizingprioritizing marketingmarketing focusfocus..
22.. ToTo provideprovide ComprehensiveComprehensive understandingunderstanding ofof globalglobal regulatoryregulatory guidelinesguidelines enablingenabling
thethe pharmaceuticalpharmaceutical organizationsorganizations toto assessassess theirtheir shortcomingsshortcomings..
33.. CreateCreate awarenessawareness aboutabout thethe minimumminimum basicbasic levellevel ofof productionproduction systemssystems ii..ee..
manufacturingmanufacturing facilities,facilities, design,design, equipmentequipment andand qualityquality managementmanagement systemssystems likelike
documentationsdocumentations andand controlscontrols etcetc..
44.. ToTo generategenerate positivepositive outlookoutlook toto faceface thethe challengechallenge confidentlyconfidently ratherrather thanthan takingtaking
thethe escapeescape routeroute ii..ee.. waitwait andand watchwatch policypolicy oror believebelieve in”in” WhateverWhatever willwill happenhappen toto
thethe othersothers willwill happenhappen toto me”me”..
55.. GeneratingGenerating aa perfectperfect clarityclarity aboutabout thethe regulatoryregulatory impactimpact –– itsits positivepositive
interpretationinterpretation andand approachapproach toto implementimplement thethe necessarynecessary changeschanges inin technologytechnology
andand businessbusiness plansplans..
66.. DevelopingDeveloping anan insightinsight amongamong thethe PharmaceuticalPharmaceutical industries/institutes'industries/institutes' toto prepareprepare
challengeschallenges ofof GlobalizationGlobalization..
Our MissionOur Mission

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Regulatory Approval Requires:
1. Qualified Facilities
2. Qualified Equipments ,Instruments and Utilities
3. Qualified Methods and Processes
4. Qualified personnel
5. Risk Assessment
6. Registration and regulatory submissions
7. Flawless Documentation
M/s. Sai Pharma Solutions has been catering above requirements of our
esteemed customers since 2008 .
Goal is : Regulatory ApprovalGoal is : Regulatory Approval

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What We Offer……?What We Offer……?
1. ProvidingProviding consultingconsulting andand resourcesresources forfor validationvalidation andand qualificationqualification activitiesactivities
2.2. ConsultingConsulting onon howhow toto combinecombine GMPGMP compliancecompliance withwith TotalTotal QualityQuality
Management(TQM)Management(TQM) andand continuouscontinuous improvementimprovement techniquestechniques..
3.3. ConsultingConsulting onon GxPGxP compliancecompliance
4.4. ConsultingConsulting onon QualityQuality ComplianceCompliance
5.5. ConsultingConsulting onon RegulatoryRegulatory ComplianceCompliance
6.6. TrainingTraining PeoplePeople inin Validation,Validation, GMPGMP Compliance,Compliance, Documentation,Documentation, ContinuousContinuous
improvementimprovement andand careercareer enhanceenhance trainingtraining inin RA,QA,QC,ADL,RA,QA,QC,ADL, Manufacturing,Manufacturing, IPRIPR
etcetc..
7.7. ConsultingConsulting onon USFDA,PMDA,Japan,USFDA,PMDA,Japan, EU,EU, EDQM,TGA,EDQM,TGA, MCC,MHRAMCC,MHRA andand RestRest ofof thethe
world(ROW)world(ROW) DrugDrug registrationregistration
WeWe tackletackle validation,validation, qualification,qualification, registration,registration, documentationdocumentation compliancecompliance andand
ContinuousContinuous improvementimprovement projectsprojects onon aa fixedfixed priceprice oror hourlyhourly raterate basisbasis..

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Our Team IncludesOur Team Includes
1.Regulatory Affairs Consultants
2. Professional Trainers
3. Validation Consultants
4. Pharmaceutical Engineers
5. R&D and F&D Experts
6. GMP Consultants
7. Quality Management Consultants
8. Analytical Development and Validation Consultants

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We undertake GAP analysis for the following activities:
1. Design Support for the upcoming manufacturing facilities.
2. New Manufacturing building and facilities
3. New Laboratory Establishment
4. Quality System Development and Implementation
5. To meet global regulatory requirements
6. Existing facilities for Quality System Improvement
We Offer : GAP AnalysisWe Offer : GAP Analysis

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We undertake Audit services and provide checklists for :
1. Internal Audits
2. Third Party Audits for Vendor Qualification
3. Mock audits prior to Regulatory and Customer Audits
4. Support for Audit Preparation
5. Audit Checklists
6. Master Document Check List
We Offer : Audits and ChecklistsWe Offer : Audits and Checklists

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We identify SOPs as per your business module, prepare
them and impart training prior to their implementation:
1. System SOPs
2. General SOPs
3. Cleaning and Sanitation SOPs
4. Passivation SOPs
5. Departmental SOPs : QA,QC, Personnel & Admin,
Microbiology, Engineering, R&D and Warehouse etc.
6. Validation and Qualification SOPs
7. Operation and Calibration SOPs
8. Preventive Maintenance SOPs
We Offer : Standard Operating ProceduresWe Offer : Standard Operating Procedures

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We conduct following trainingWe conduct following training programs but not limited to:programs but not limited to:
••CFRCFR 210210 && 211211
••European PharmaceuticalEuropean Pharmaceutical
••ASEAN Member Country RegulationsASEAN Member Country Regulations
••Japanese Pharmaceutical RegulationsJapanese Pharmaceutical Regulations
••QQ77 (For API manufacturer)(For API manufacturer)
••Ayurvedic and Herbal Product ManufacturesAyurvedic and Herbal Product Manufactures
••Cosmetic ManufacturesCosmetic Manufactures
•• Pharmaceutical Educational InstitutesPharmaceutical Educational Institutes
••On Job trainingOn Job training
••Training to Departmental heads to certify as internal trainerTraining to Departmental heads to certify as internal trainer
••Specialize training for QC, QA & ManufacturingSpecialize training for QC, QA & Manufacturing
••GMP related topics / GuidelinesGMP related topics / Guidelines
••(e.g. HVAC, water system qualification, OOS, SOP preparation, regulatory(e.g. HVAC, water system qualification, OOS, SOP preparation, regulatory
requirements while Specification designing, Analytical method Validation, procedurerequirements while Specification designing, Analytical method Validation, procedure
validation etc)validation etc)
•• Career enhancement trainingCareer enhancement training
We conduct inWe conduct in--house/ indoor/ outdoor training programmes. We also train thehouse/ indoor/ outdoor training programmes. We also train the
trainers internationally.trainers internationally.
We Offer : Training and Development ProgramsWe Offer : Training and Development Programs

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We offer the following documentation services but not limited to:We offer the following documentation services but not limited to:
1.1. Site Master File( As per WHO/EUSite Master File( As per WHO/EU--GMP/PIC/s requirements)GMP/PIC/s requirements)
2.2. Validation Master Plan(VMP)Validation Master Plan(VMP)
3.3. Quality ManualQuality Manual
4.4. Specifications and Analytical Procedures as per Regulatory RequirementSpecifications and Analytical Procedures as per Regulatory Requirement
5.5. Master Production and Control Record(MPCR)Master Production and Control Record(MPCR)
6.6. Batch Production and Control Record(BPCR)Batch Production and Control Record(BPCR)
7.7. Validation Activities( Process Validation, Cleaning Validation, Analytical Method ValidationValidation Activities( Process Validation, Cleaning Validation, Analytical Method Validation
etc.)etc.)
8.8. Qualification of Equipments, instruments and utilities( URS,DQ,FAT,SAT,IQ,OQ and PQ) asQualification of Equipments, instruments and utilities( URS,DQ,FAT,SAT,IQ,OQ and PQ) as
per ISPE guidelinesper ISPE guidelines
9.9. Preventive Maintenance ChecklistsPreventive Maintenance Checklists
10.10. Quality and GMP records and reportsQuality and GMP records and reports
11.11. MSDS design as per REACH complianceMSDS design as per REACH compliance
12.12. Genotoxic Impurities and Polymorphism StudyGenotoxic Impurities and Polymorphism Study
13.13. Environment, Health and Safety(EHS) documentationEnvironment, Health and Safety(EHS) documentation
14.14. API and Impurity characterization and structural elucidationAPI and Impurity characterization and structural elucidation
15.15. Process/ Product Development Report( PDR)Process/ Product Development Report( PDR)
16.16. Technology Transfer DocumentationTechnology Transfer Documentation
17.17. Chemist/ Analyst ValidationChemist/ Analyst Validation
We Offer : Documentation ServicesWe Offer : Documentation Services

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We undertake the following validation and qualification services.
We execute validation and qualification activities as per the pre-
approved protocol and compile the report based on the
observations and findings. Protocol is also designed and
prepared by us:
1. Process Validation
2. Cleaning Validation
3. Analytical Method Development
4. Analytical Method Validation
5. Equipment/ Instrument Qualification
( URS, DQ,FAT,SAT, IQ, OQ, PQ and MQ)
6. Facility Qualification
7. Utility Qualification
8. Risk Assessment
9. Successful Technology Transfer
We Undertake : Validation and QualificationWe Undertake : Validation and Qualification

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RegulatoryRegulatory ServicesServices areare thethe cornercorner stonestone toto thethe businessbusiness successsuccess.. WeWe offeroffer
followingfollowing regulatoryregulatory affairsaffairs servicesservices toto ensureensure youryour businessbusiness forayforay inin toto thethe
regulatedregulated marketsmarkets::
1.1. TechnicalTechnical DataData PackagePackage forfor APIs/APIs/ Intermediates/Intermediates/ StartingStarting MaterialsMaterials
2.2. DrugDrug MasterMaster FilesFiles inin CTD/CTD/ ACTD/ACTD/ ee--CTDCTD // countrycountry specificspecific formatformat
3.3. DrugDrug ProductProduct DossierDossier inin CTD,CTD, ACTD,ACTD, ee--CTDCTD oror countrycountry specificspecific formatsformats
4.4. DocumentDocument ReviewReview
5.5. FacilityFacility // ProductProduct Registration/Registration/ SiteSite AccreditationAccreditation etcetc..
6.6. RegulatoryRegulatory SubmissionsSubmissions
7.7. ResponseResponse toto regulatoryregulatory andand customercustomer queriesqueries
8.8. DueDue diligencediligence
9.9. AnnualAnnual UpdatesUpdates
10.10.Amendment/Amendment/ VariationVariation FilingFiling
We Offer: Regulatory Affairs ServicesWe Offer: Regulatory Affairs Services

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WeWe extendextend supportsupport inin regulatoryregulatory documentdocument preparation,preparation, review,review,
submissionsubmission andand registrationregistration ofof drugsdrugs andand approvalapproval ofof facilitiesfacilities
forfor::
1.1. SiteSite Accreditation/RegistrationAccreditation/Registration
2.2. ProductProduct RegistrationRegistration
3.3. ScheduleSchedule ––MM GMPGMP
4.4. StateState GMP(IssuedGMP(Issued byby thethe FDCAFDCA ofof statesstates ofof IndianIndian union)union)
5.5. WHOWHO ––GMPGMP CertificationCertification
6.6. COS/CEPCOS/CEP grantinggranting andand supportsupport inin hostinghosting EDQMEDQM inspectioninspection
7.7. USPUSP VerificationVerification forfor APIsAPIs andand ExcipientsExcipients
8.8. EUEU GMP/GMP/ CEPCEP--EDQM/EDQM/ USFDA/USFDA/ PMDA,PMDA, Japan/Japan/ MHRA,UK/MCCMHRA,UK/MCC ,, SouthSouth
Africa/TGAAfrica/TGA andand RestRest ofof thethe World(ROW)World(ROW)
9.9. ISOISO--90019001--20082008 andand ISOISO--1400014000 DocumentationDocumentation SupportSupport
10.10.NABLNABL AccreditationAccreditation
11.11.REACHREACH ComplianceCompliance MSDSMSDS andand LabelLabel DesignDesign
We Offer: Approval and Accreditation SupportWe Offer: Approval and Accreditation Support

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WeWe tackletackle youryour scientificscientific andand technicaltechnical queriesqueries pertainingpertaining toto
regulatory/regulatory/ GMP/GMP/ QualityQuality compliancecompliance::
1. Facility Design Requirement
2. Product Development
3. QbD Documentation(PDR etc)
4. Chemistry and Manufacturing Controls
5. Product Quality and Safety Issues
6. Contamination Issues
7. Change Control Issues
8. Deviation Issues
9. Patent and IPR discussion
10. Regulatory Discussion
11. Equipment/ Instrument requirement
12.Water System Requirement
13. AHU/HVAC System requirement
14.Unit Operation Discussion
15. Compressed gas requirement discussion
16. Product contact utility discussion
We Offer: Scientific and Technical Discussions

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We extend support both the vendors and customers for business
development through a strategic alliance and agreements. We support
for:
1. Vendor Development
2. Technical Data Package at the product development stage
3. Impurity Standards
4. Customer Development Samples
5. Audit for Vendor Qualification
We Support in: Product and Business DevelopmentWe Support in: Product and Business Development

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Our company is the first pharmaceutical GMP consulting service provider in India to be
based entirely on the Internet. We work closely with experienced and highly skilled
professional GMP experts from around the world, allowing you to benefit from their wide-
ranging knowledge and expertise. As a result, pharmaceutical companies no longer need to
spend several thousands of dollars on conventional consulting services to gather GMP-
related information.
Our role is to find the right answers to your questions and provide advice as and when you
need it. We specialize in conducting GMP and quality reviews in both English and local
languages for batch records, annual product reviews, investigations, complaints and
deviations, etc. We can also assist you in the creation of documentation such as master batch
records and standard operating procedures (SOPs).
We also provide key pharmaceutical document templates such as SOPs, master plans and
training modules to support your daily cGMP affairs. What’s more, as an Internet-based
consultancy, we don’t generate costly travel and hotel expenses. Instead, we focus entirely on
the task in hand – providing you and your company with precisely the advice or
documentation you need in the most cost-effective manner.
We Offer: Online ConsultancyWe Offer: Online Consultancy

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There are many reasons that you get associated with us for all Regulatory Affairs,
Quality and GMP compliance solutions. Some of them are enumerated below:
1. Meeting set targets within stipulated timelines
2. Compliance with Global Quality Standards.
3. Proven Past Track Record
4. Commitment to Quality and Timely deliverance.
5. Interacting with the personnel on shop floor to resolve issues
6. Qualified and Competitive team.
7. Professional Excellence
8. Quality at a Reasonable cost.
9. Ready to face audits by worldwide Regulatory authorities.
10. Conducting audits for European/ Japanese customers in accordance with
EDQM/EMEA/PMDA requirements
11. Outsourcing can reduce the overhead costs
Why Sai Pharma Solutions…..?Why Sai Pharma Solutions…..?

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We have customers in various pharmaceutical fields in India and overseas to whom
we are providing our value added services on continuous basis. Our Indian customers:
1. Titan Laboratories Private Limited 23. Amoli Organics Pvt Ltd
2. Titan Pharma Pvt Limited 24. UBM India Limited
3. Nivika Chemo Pharma Private Limited 25. Anamayee Pharmachem Pvt Ltd
4. Suchem Laboratories 26. Danopharm Chemicals P Limited
5. Suleshvari Pharma
6. Dolphin Chem
7. Anuh Pharma Limited
8. Orex Pharma Private Limited
9. Apex Healthcare Limited
10. Great Pacific Export Limited
11. Anan Drugs and Chem Limited
12. Annamalai University
13. Gujarat University
14. Asia Business Forum
15. IBC(Asia)
16. Parul Institute of Pharmacy
17. Isomatric Health Care Limited
18. Adani Pharmachem Private Limited
19. Benzo Petro International Limited ( Arch Pharmalabs Limited)
20. SICART
21. Zephyr Synthesis Private Limited
22. Rubamin Limited(Pharma Division)
***In addition to India, we have customers in South Asian countries and other parts of the world.***In addition to India, we have customers in South Asian countries and other parts of the world.
Our Esteemed CustomersOur Esteemed Customers

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J.RAMNIWAS (International speaker,writer, auditor and Regulatory & QMS technical advisor)
( Founder and CEO)
102102,Shraddha Saburi,,Shraddha Saburi,
Narayan Gardens, VUDA Road, GotriNarayan Gardens, VUDA Road, Gotri --390021390021
Vadodara (Gujarat) IndiaVadodara (Gujarat) India
Email:Email: jramniwas@saipharmasolutions.comjramniwas@saipharmasolutions.com
Phone No: +Phone No: +919558809128919558809128
Website:Website: www.saipharmasolutions.comwww.saipharmasolutions.com
Contact us for business associationContact us for business association