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SAI PHARMA SOLUTIONS INC.


We Offer : Online Consultancy
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
                                                                                                                                        SAI
advice or documentation you need in the most cost-effective manner.



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:

•   Meeting set targets within stipulated timelines
•
•
•
    Compliance with Global Quality Standards.
    Proven Past Track Record
    Commitment to Quality and Timely deliverance.
                                                                                                                         SAI PHARMA SOLUTIONS INC.
•   Interacting with the personnel on shop floor to resolve issues                                                       Gateway to Regulatory Affairs
•   Qualified and Competitive team.
•   Professional Excellence                                                                                              Quality and cGMP Compliance
•   Quality at a Reasonable cost.                                                          J. RAMNIWAS
•   Ready to face audits by worldwide Regulatory authorities.
•   Conducting audits for European/ Japanese customers in                                    Founder & CEO
     accordance with EDQM/EMEA/PMDA requirements

                                                                                                                                         Our motto
                                                                                                                         “Start to finish,everything in between”
                                                Contact us:
                                     102, Shraddha Saburi,
             Narayan Gardens, VUDA Road,Gotri -390021, Vadodara (Gujarat) India
                         Email: jramniwas@saipharmasolutions.com
              Phone No: +919558809128, Website: www.saipharmasolutions.com
SAI PHARMA SOLUTIONS INC.                                                                                                               SAI PHARMA SOLUTIONS INC.

Introduction                                                                                                                          We Offer : Training and                                        We Offer : Documentation
Sai Pharma Solutions Inc is a boutiqueconsultancy to the pharmaceutical industries dealing in
¥ API Manufacturing                                                                                                                   Development Programs                                           Services
¥ Drug Product Manufacturing
¥ Cosmetic Manufacturing                                                                                                              We conduct following training programs:                        We offer the following documentation services
¥ Ayurvedic and Herbal Product                                                                                                        • CFR 210 & 211
                                                                                                                                      • European Pharmaceutical
                                                                                                                                                                                                     but not limited to:
  Manufacturing                                                                                                                                                                                      • Site Master File( As per WHO/EU-GMP/PIC/s
¥ Biological/ Biotechnological Product Manufacturing                                                                                  • ASEAN Member Country Regulations
                                                                                                                                                                                                       requirements)
  We consult and train on Regulatory, GMP , Quality compliance,Drug registration, validation, qualification and                       • Japanese Pharmaceutical Regulations
                                                                                                                                                                                                     • Validation Master Plan(VMP)
  continuous improvement of manufacturing process                                                                                     • Q7 (For API manufacturer)
                                                                                                                                                                                                     • Quality Manual
                                                                                                                                      • Ayurvedic and Herbal Product Manufactures
                                                                                                                                                                                                     • Specifications and Analytical Procedures as per
                                                                                                                                      • Cosmetic Manufactures
                                                                                                                                                                                                       Regulatory Requirement
Our Vision                                                                                                                            • Pharmaceutical Educational Institutes
                                                                                                                                                                                                     • Master Production and Control Record(MPCR)
                                                                                                                                      • On Job training
Preparing Pharmaceutical Industries/Institutes for Global Regulatory Compliance by education, training, auditing,                                                                                    • Batch Production and Control Record(BPCR)
                                                                                                                                      • Training to Departmental heads to certify as
documentation and regulatory submissions by way of generating awareness among the pharmaceutical entrepreneurs                                                                                       • Validation Activities( Process Validation, Cleaning
                                                                                                                                        internal trainer
regarding the future course of the regulatory mechanism and increasing customer's expectations consequential technical up                                                                              Validation, Analytical Method Validation etc.)
                                                                                                                                      • Specialize training for QC, QA & Manufacturing
gradation for pharmaceutical manufacturing facilities.                                                                                                                                               • Qualification of Equipments, instruments and utilities(
                                                                                                                                      • GMP related topics / Guidelines (e.g. HVAC, water
                                                                                                                                                                                                       URS,DQ,FAT,SAT,IQ,OQ and PQ) as per ISPE guidelines
                                                                                                                                         system qualification, OOS, SOP
                                                                                                                                                                                                     • Preventive Maintenance Checklists
                                                                                                                                         preparation, regulatory requirements while
Our Mission                                                                                                                             Specification designing, Analytical method
                                                                                                                                                                                                     • Quality and GMP records and reports
                                                                                                                                                                                                     • MSDS design as per REACH compliance
                                                                                                                                        Validation, procedure validation etc)
1. Making Pharmaceutical Industries/ Institutes appreciate the need to change and prepare a systematic action plan for                                                                               • Genotoxic Impurities and Polymorphism Study
                                                                                                                                      • Career enhancement training
   reviewing “Manufacturing Activities and Quality Systems” vis-a-vis traditional approach of prioritizing marketing focus.                                                                          • Environment, Health and Safety(EHS) documentation
                                                                                                                                        We conduct in-house/ indoor/ outdoor training
                                                                                                                                                                                                     • API and Impurity characterization and structural
                                                                                                                                        programmes. We also train the trainers
2. To provide Comprehensive understanding of global regulatory guidelines enabling the pharmaceutical organizations to assess                                                                          elucidation
                                                                                                                                        internationally.
     their short comings.                                                                                                                                                                            • Process/ Product Development Report( PDR)
                                                                                                                                                                                                     • Technology Transfer Documentation
3. Create awareness about the minimum basic level of production systems i.e. manufacturing facilities, design, equipment and                                                                         • Chemist/ Analyst Validation internationally.
    quality management systems like documentation 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      We Offer : Regulatory Affairs                                   We Offer : Approval and
    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               Services                                                        Accreditation Support
    necessary changes in technology and business plans.
                                                                                                                                      Regulatory Services are the corner stone to the                We extend support in regulatory document
6. Developing an insight among the Pharmaceutical industries/institutes' to prepare challenges of Globalization.
                                                                                                                                      business success. We offer following regulatory                preparation, review, submission and registration of
                                                                                                                                      affairs services to ensure your business foray in to
Pharmaceutical Manufacturer's                                        We Undertake : Validation                                        the regulated markets:
                                                                                                                                                                                                     drugs and approval of facilities for:

Goal is Regulatory Approval                                          and Qualification                                                                                                               • Schedule –M GMP
                                                                                                                                      •   Technical Data Package for APIs/ Intermediates/            • State GMP
Regulatory Approval Requires:                                       We undertake the following validation and qualification               Starting Materials                                         • WHO –GMP ( Both CDSCO and Geneva)
•   Qualified Facilities                                            services. We execute validation and qualification activities as   •   Drug Master Files in CTD/ ACTD/ e-CTD / country            • COS granting and support in hosting EDQM inspection
•   Qualified Equipments ,Instruments and Utilities                 per the pre-approved protocol and compile the report based            specific format                                            • USP Verification for APIs and Excipients
•   Qualified Methods and Processes                                 on the observations and findings. Protocol is also designed       •   Drug Product Dossier in CTD, ACTD, e-CTD or country        • EU GMP/ CEP-EDQM/ USFDA/ PMDA, Japan/
•   Qualified Personnel                                             and prepared by us:                                                   specific formats                                             MHRA,UK/MCC , South Africa/TGA and Rest of the
                                                                    Ÿ Process Validation                                              •   Document Review                                              World(ROW)
Sai Pharma Solutions Can Support to cater all the above             Ÿ Cleaning Validation                                             •   Facility / Product Registration/ Site Accreditation etc.   • ISO-9001-2008 and ISO-14000 Documentation Support
Requirements.                                                       Ÿ Analytical Method Validation                                    •   Regulatory Submissions                                     • NABL Accreditation
                                                                    Ÿ Equipment/ Instrument Qualification( URS, DQ,FAT,SAT,           •   Response to regulatory and customer queries                • REACH Compliance MSDS and Label Design
                                                                        IQ, OQ, PQ and MQ)                                            •   Due diligence
Our motto                                                           Ÿ Facility Qualification                                          •   Annual Updates                                             Our motto
                                                                    Ÿ Utility Qualification                                           •   Amendment/ Variation Filing
“Start to finish,everything in between”                                                                                                                                                              “Start to finish,everything in between”

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Sai pharma solutions inc a gateway of regulatory affairs,quality managment and gmp compliance-1

  • 1. SAI PHARMA SOLUTIONS INC. We Offer : Online Consultancy 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 SAI advice or documentation you need in the most cost-effective manner. 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: • Meeting set targets within stipulated timelines • • • Compliance with Global Quality Standards. Proven Past Track Record Commitment to Quality and Timely deliverance. SAI PHARMA SOLUTIONS INC. • Interacting with the personnel on shop floor to resolve issues Gateway to Regulatory Affairs • Qualified and Competitive team. • Professional Excellence Quality and cGMP Compliance • Quality at a Reasonable cost. J. RAMNIWAS • Ready to face audits by worldwide Regulatory authorities. • Conducting audits for European/ Japanese customers in Founder & CEO accordance with EDQM/EMEA/PMDA requirements Our motto “Start to finish,everything in between” Contact us: 102, Shraddha Saburi, Narayan Gardens, VUDA Road,Gotri -390021, Vadodara (Gujarat) India Email: jramniwas@saipharmasolutions.com Phone No: +919558809128, Website: www.saipharmasolutions.com
  • 2. SAI PHARMA SOLUTIONS INC. SAI PHARMA SOLUTIONS INC. Introduction We Offer : Training and We Offer : Documentation Sai Pharma Solutions Inc is a boutiqueconsultancy to the pharmaceutical industries dealing in ¥ API Manufacturing Development Programs Services ¥ Drug Product Manufacturing ¥ Cosmetic Manufacturing We conduct following training programs: We offer the following documentation services ¥ Ayurvedic and Herbal Product • CFR 210 & 211 • European Pharmaceutical but not limited to: Manufacturing • Site Master File( As per WHO/EU-GMP/PIC/s ¥ Biological/ Biotechnological Product Manufacturing • ASEAN Member Country Regulations requirements) We consult and train on Regulatory, GMP , Quality compliance,Drug registration, validation, qualification and • Japanese Pharmaceutical Regulations • Validation Master Plan(VMP) continuous improvement of manufacturing process • Q7 (For API manufacturer) • Quality Manual • Ayurvedic and Herbal Product Manufactures • Specifications and Analytical Procedures as per • Cosmetic Manufactures Regulatory Requirement Our Vision • Pharmaceutical Educational Institutes • Master Production and Control Record(MPCR) • On Job training Preparing Pharmaceutical Industries/Institutes for Global Regulatory Compliance by education, training, auditing, • Batch Production and Control Record(BPCR) • Training to Departmental heads to certify as documentation and regulatory submissions by way of generating awareness among the pharmaceutical entrepreneurs • Validation Activities( Process Validation, Cleaning internal trainer regarding the future course of the regulatory mechanism and increasing customer's expectations consequential technical up Validation, Analytical Method Validation etc.) • Specialize training for QC, QA & Manufacturing gradation for pharmaceutical manufacturing facilities. • Qualification of Equipments, instruments and utilities( • GMP related topics / Guidelines (e.g. HVAC, water URS,DQ,FAT,SAT,IQ,OQ and PQ) as per ISPE guidelines system qualification, OOS, SOP • Preventive Maintenance Checklists preparation, regulatory requirements while Our Mission Specification designing, Analytical method • Quality and GMP records and reports • MSDS design as per REACH compliance Validation, procedure validation etc) 1. Making Pharmaceutical Industries/ Institutes appreciate the need to change and prepare a systematic action plan for • Genotoxic Impurities and Polymorphism Study • Career enhancement training reviewing “Manufacturing Activities and Quality Systems” vis-a-vis traditional approach of prioritizing marketing focus. • Environment, Health and Safety(EHS) documentation We conduct in-house/ indoor/ outdoor training • API and Impurity characterization and structural programmes. We also train the trainers 2. To provide Comprehensive understanding of global regulatory guidelines enabling the pharmaceutical organizations to assess elucidation internationally. their short comings. • Process/ Product Development Report( PDR) • Technology Transfer Documentation 3. Create awareness about the minimum basic level of production systems i.e. manufacturing facilities, design, equipment and • Chemist/ Analyst Validation internationally. quality management systems like documentation 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 We Offer : Regulatory Affairs We Offer : Approval and 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 Services Accreditation Support necessary changes in technology and business plans. Regulatory Services are the corner stone to the We extend support in regulatory document 6. Developing an insight among the Pharmaceutical industries/institutes' to prepare challenges of Globalization. business success. We offer following regulatory preparation, review, submission and registration of affairs services to ensure your business foray in to Pharmaceutical Manufacturer's We Undertake : Validation the regulated markets: drugs and approval of facilities for: Goal is Regulatory Approval and Qualification • Schedule –M GMP • Technical Data Package for APIs/ Intermediates/ • State GMP Regulatory Approval Requires: We undertake the following validation and qualification Starting Materials • WHO –GMP ( Both CDSCO and Geneva) • Qualified Facilities services. We execute validation and qualification activities as • Drug Master Files in CTD/ ACTD/ e-CTD / country • COS granting and support in hosting EDQM inspection • Qualified Equipments ,Instruments and Utilities per the pre-approved protocol and compile the report based specific format • USP Verification for APIs and Excipients • Qualified Methods and Processes on the observations and findings. Protocol is also designed • Drug Product Dossier in CTD, ACTD, e-CTD or country • EU GMP/ CEP-EDQM/ USFDA/ PMDA, Japan/ • Qualified Personnel and prepared by us: specific formats MHRA,UK/MCC , South Africa/TGA and Rest of the Ÿ Process Validation • Document Review World(ROW) Sai Pharma Solutions Can Support to cater all the above Ÿ Cleaning Validation • Facility / Product Registration/ Site Accreditation etc. • ISO-9001-2008 and ISO-14000 Documentation Support Requirements. Ÿ Analytical Method Validation • Regulatory Submissions • NABL Accreditation Ÿ Equipment/ Instrument Qualification( URS, DQ,FAT,SAT, • Response to regulatory and customer queries • REACH Compliance MSDS and Label Design IQ, OQ, PQ and MQ) • Due diligence Our motto Ÿ Facility Qualification • Annual Updates Our motto Ÿ Utility Qualification • Amendment/ Variation Filing “Start to finish,everything in between” “Start to finish,everything in between”