Pharmaceutical Regulatory Affairs, Quality Managment and GMP Consulting Services

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

2. Introduction
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
We consult and train on Regulatory , GMP , Quality compliance,
Drug registration, validation, qualification and continuous
improvement of manufacturing process.
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3. Our Vision
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.
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4. Our Mission
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.
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5. Goal is : Regulatory Approval
Regulatory Approval Requires:
1. Qualified Facilities
2. Qualified Equipments ,Instruments and Utilities
3. Qualified Methods and Processes
4. Qualified personnel
Sai Pharma Solutions Can Support to cater all
the above Requirements.
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6. 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.
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.
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.
basis.
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7. 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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8. We Offer : GAP Analysis
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
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9. We Offer : Audits and Checklists
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
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10. We Offer : Standard Operating Procedures
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
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16. We Offer: Scientific and Technical Discussions
We tackle your scientific and technical queries pertaining to
regulatory/ GMP/ Quality compliance:
compliance:
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17. We Support in: Product and Business Development
We extend support both the vendors and customers for business
development through a strategic alliance and agreements. We
agreements.
support for:
for:
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18. We Offer: Online Consultancy
Our company is the 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.
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19. Why Sai Pharma Solutions…..?
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:
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20. Our Esteemed Customers
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
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.
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21. Contact us for business association
J.RAMNIWAS
( Founder and CEO)
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