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)

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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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Our Consulting Services Highlights
1. Writing Dossiers for Pharmaceutical Formulations, Preparation and
compilation of Drug Master Files(DMF)
2. Expertise in writing Dossiers in CTD ,ACTD ,NeeS and eCTD Format
3. Accepting projects for Advising pharmaceutical Industries for
Preparation of USFDA,WHO,PMDA MHRA,TGA Audits
4. Ready Database for Preparation of DMF AND DOSSIERS,CTD Files or
ACTD Files
5. Resolving Regulatory Queries of DOSSIERS and DMF's or CTD
6. Advice on facility design, validation and operation
7. Review of validation plans and completed studies
8. Experts opinion on the Guidelines for Drug Master File ,DMF and
Dossiers for submission to regulatory authorities
9. Specialist advice on water systems Validation
10.Specialist Advise on AHU Validation Services
11.Expert Periodic Audit /GAP analysis services
12.Validation and Qualification Services
13.SOP and documentation services
14.Training and Development Services
15.All GMP, Quality Management and Regulatory Documentation

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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 23 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(IPA)
• 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.
Introduction

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Preparing Pharmaceutical Industries/Institutes for Global
Regulatory Compliance by education, training, auditing,
documentation and regulatory submissions by way of generating
awareness among the pharmaceutical entrepreneurs regarding
the future course of the regulatory mechanism and increasing
customer's expectations consequential technical upgradation for
pharmaceutical manufacturing facilities.
Our Vision

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1. Making Pharmaceutical Industries/ Institutes appreciate the need to change and
prepare a systematic action plan for reviewing “Manufacturing Activities and
Quality Systems” vis-a-vis traditional approach of prioritizing marketing focus.
2. To provide Comprehensive understanding of global regulatory guidelines enabling
the pharmaceutical organizations to assess their shortcomings.
3. Create awareness about the minimum basic level of production systems i.e.
manufacturing facilities, design, equipment and quality management systems like
documentations and controls etc.
4. To generate positive outlook to face the challenge confidently rather than taking
the escape route i.e. wait and watch policy or believe in” Whatever will happen to
the others will happen to me”.
5. Generating a perfect clarity about the regulatory impact – its positive
interpretation and approach to implement the necessary changes in technology
and business plans.
6. Developing an insight among the Pharmaceutical industries/institutes' to prepare
challenges of Globalization.
Our 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 Approval

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What We Offer……?
1. Providing consulting and resources for validation and qualification activities
2. Consulting on how to combine GMP compliance with Total Quality
Management(TQM) and continuous improvement techniques.
3. Consulting on GxP compliance
4. Consulting on Quality Compliance
5. Consulting on Regulatory Compliance
6. Training People in Validation, GMP Compliance, Documentation, Continuous
improvement and career enhance training in RA,QA,QC,ADL, Manufacturing, IPR
etc.
7. Consulting on USFDA,PMDA,Japan, EU, EDQM,TGA, MCC,MHRA and Rest of the
world(ROW) Drug registration
We tackle validation, qualification, registration, documentation compliance and
Continuous improvement projects on a fixed price or hourly rate basis.

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Our 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 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 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 Procedures

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We conduct following training programs but not limited to:
•CFR 210 & 211
•European Pharmaceutical
•ASEAN Member Country Regulations
•Japanese Pharmaceutical Regulations
•Q7 (For API manufacturer)
•Ayurvedic and Herbal Product Manufactures
•Cosmetic Manufactures
• Pharmaceutical Educational Institutes
•On Job training
•Training to Departmental heads to certify as internal trainer
•Specialize training for QC, QA & Manufacturing
•GMP related topics / Guidelines
•(e.g. HVAC, water system qualification, OOS, SOP preparation, regulatory
requirements while Specification designing, Analytical method Validation, procedure
validation etc)
• Career enhancement training
We conduct in-house/ indoor/ outdoor training programmes. We also train the
trainers internationally.
We Offer : Training and Development Programs

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We offer the following documentation services but not limited to:
1. Site Master File( As per WHO/EU-GMP/PIC/s requirements)
2. Validation Master Plan(VMP)
3. Quality Manual
4. Specifications and Analytical Procedures as per Regulatory Requirement
5. Master Production and Control Record(MPCR)
6. Batch Production and Control Record(BPCR)
7. Validation Activities( Process Validation, Cleaning Validation, Analytical Method Validation
etc.)
8. Qualification of Equipments, instruments and utilities( URS,DQ,FAT,SAT,IQ,OQ and PQ) as
per ISPE guidelines
9. Preventive Maintenance Checklists
10. Quality and GMP records and reports
11. MSDS design as per REACH compliance
12. Genotoxic Impurities and Polymorphism Study
13. Environment, Health and Safety(EHS) documentation
14. API and Impurity characterization and structural elucidation
15. Process/ Product Development Report( PDR)
16. Technology Transfer Documentation
17. Chemist/ Analyst Validation
We 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 Qualification

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Regulatory Services are the corner stone to the business success. We offer
following regulatory affairs services to ensure your business foray in to the
regulated markets:
1. Technical Data Package for APIs/ Intermediates/ Starting Materials
2. Drug Master Files in CTD/ ACTD/ e-CTD / country specific format
3. Drug Product Dossier in CTD, ACTD, e-CTD or country specific formats
4. Document Review
5. Facility / Product Registration/ Site Accreditation etc.
6. Regulatory Submissions
7. Response to regulatory and customer queries
8. Due diligence
9. Annual Updates
10.Amendment/ Variation Filing
We Offer: Regulatory Affairs Services

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We extend support in regulatory document preparation, review,
submission and registration of drugs and approval of facilities
for:
1. Site Accreditation/Registration
2. Product Registration
3. Schedule –M GMP
4. State GMP(Issued by the FDCA of states of Indian union)
5. WHO –GMP Certification
6. COS/CEP granting and support in hosting EDQM inspection
7. USP Verification for APIs and Excipients
8. EU GMP/ CEP-EDQM/ USFDA/ PMDA, Japan/ MHRA,UK/MCC , South
Africa/TGA and Rest of the World(ROW)
9. ISO-9001-2008 and ISO-14000 Documentation Support
10.NABL Accreditation
11.REACH Compliance MSDS and Label Design
We Offer: Approval and Accreditation Support

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We tackle your scientific and technical queries pertaining to
regulatory/ GMP/ Quality compliance:
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 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 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…..?

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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.
Our Esteemed Customers

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J.RAMNIWAS (International speaker, writer, auditor and Regulatory & QMS technical advisor)
( Founder and CEO)
102,Shraddha Saburi,
Narayan Gardens, VUDA Road, Gotri -390021
Vadodara (Gujarat) India
Email: jramniwas@saipharmasolutions.com
Phone No: +919558809128
Website: www.saipharmasolutions.com
Contact us for business association