INSIGHT OF OUR QUALITY MANAGEMENT ANDREGULATORY AFFAIRS CONSULTING SERVICES  By:  J.Ramniwas(M.Sc , M.Phil –Medicinal Chem...
IntroductionSai Pharma Solutions Inc is a boutique consultancy tothe pharmaceutical industries dealing in1. API Manufactur...
Our VisionPreparing    Pharmaceutical        Industries/Institutes   for     GlobalRegulatory   Compliance       by     ed...
Our Mission1. Making Pharmaceutical Industries/ Institutes appreciate the need to change and     prepare a systematic acti...
Goal is : Regulatory ApprovalRegulatory Approval Requires:1. Qualified Facilities2. Qualified Equipments ,Instruments and ...
What We Offer……?1. Providing consulting and resources for validation and qualification activities2. Consulting on how to c...
Our Team Includes1. Regulatory Affairs Consultants2. Professional Trainers3. Validation Consultants4. Pharmaceutical Engin...
We Offer : GAP AnalysisWe undertake GAP analysis for the following activities:1.   Design Support for the upcoming manufac...
We Offer : Audits and ChecklistsWe undertake Audit services and provide checklists for :1.   Internal Audits2.   Third Par...
We Offer : Standard Operating ProceduresWe identify SOPs as per your business module, preparethem and impart training prio...
We Offer: Scientific and Technical DiscussionsWe tackle your scientific and technical queries pertaining toregulatory/ GMP...
We Support in: Product and Business DevelopmentWe extend support both the vendors and customers for businessdevelopment th...
We Offer: Online ConsultancyOur company is the                                                            in India to beba...
Why Sai Pharma Solutions…..?There are many reasons that you get associated with us for all Regulatory Affairs,Quality and ...
Our Esteemed CustomersWe have customers in various pharmaceutical fields in India and overseas to whomwe are providing our...
Contact us for business association            J.RAMNIWAS          ( Founder and CEO)                                     ...
Sai pharma solutions inc  scientific-regulatory affairs-qms and c gmp consultants
Sai pharma solutions inc  scientific-regulatory affairs-qms and c gmp consultants
Sai pharma solutions inc  scientific-regulatory affairs-qms and c gmp consultants
Sai pharma solutions inc  scientific-regulatory affairs-qms and c gmp consultants
Sai pharma solutions inc  scientific-regulatory affairs-qms and c gmp consultants
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Pharmaceutical Regulatory Affairs, Quality Managment and GMP Consulting Services

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Sai pharma solutions inc scientific-regulatory affairs-qms and c gmp consultants

  1. 1. INSIGHT OF OUR QUALITY MANAGEMENT ANDREGULATORY AFFAIRS CONSULTING SERVICES By: J.Ramniwas(M.Sc , M.Phil –Medicinal Chemistry) Founder and CEO Sai Pharma Solutions Inc, Vadodara(India)
  2. 2. IntroductionSai Pharma Solutions Inc is a boutique consultancy tothe pharmaceutical industries dealing in1. API Manufacturing2. Drug Product Manufacturing3. Cosmetic Manufacturing4. Ayurvedic and Herbal Product Manufacturing5. Biological/ Biotechnological Product ManufacturingWe consult and train on Regulatory , GMP , Quality compliance,Drug registration, validation, qualification and continuousimprovement of manufacturing process. 2
  3. 3. Our VisionPreparing Pharmaceutical Industries/Institutes for GlobalRegulatory Compliance by education, training, auditing,documentation and regulatory submissions by way of generatingawareness among the pharmaceutical entrepreneurs regardingthe future course of the regulatory mechanism and increasingcustomers expectations consequential technical upgradation forpharmaceutical manufacturing facilities. 3
  4. 4. Our Mission1. 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. 4
  5. 5. Goal is : Regulatory ApprovalRegulatory Approval Requires:1. Qualified Facilities2. Qualified Equipments ,Instruments and Utilities3. Qualified Methods and Processes4. Qualified personnelSai Pharma Solutions Can Support to cater allthe above Requirements. 5
  6. 6. What We Offer……?1. Providing consulting and resources for validation and qualification activities2. Consulting on how to combine GMP compliance with Total Quality Management(TQM) and continuous improvement techniques. techniques.3. Consulting on GxP compliance4. Consulting on Quality Compliance5. Consulting on Regulatory Compliance6. 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 registrationWe tackle validation, qualification, registration, documentation compliance andContinuous improvement projects on a fixed price or hourly rate basis. basis. 6
  7. 7. Our Team Includes1. Regulatory Affairs Consultants2. Professional Trainers3. Validation Consultants4. Pharmaceutical Engineers5. R&D and F&D Experts6. GMP Consultants7. Quality Management Consultants8. Analytical Development and Validation Consultants 7
  8. 8. We Offer : GAP AnalysisWe undertake GAP analysis for the following activities:1. Design Support for the upcoming manufacturing facilities.2. New Manufacturing building and facilities3. New Laboratory Establishment4. Quality System Development and Implementation5. To meet global regulatory requirements6. Existing facilities for Quality System Improvement 8
  9. 9. We Offer : Audits and ChecklistsWe undertake Audit services and provide checklists for :1. Internal Audits2. Third Party Audits for Vendor Qualification3. Mock audits prior to Regulatory and Customer Audits4. Support for Audit Preparation5. Audit Checklists6. Master Document Check List 9
  10. 10. We Offer : Standard Operating ProceduresWe identify SOPs as per your business module, preparethem and impart training prior to their implementation:1. System SOPs2. General SOPs3. Cleaning and Sanitation SOPs4. Passivation SOPs5. Departmental SOPs : QA,QC, Personnel & Admin, Microbiology, Engineering, R&D and Warehouse etc.6. Validation and Qualification SOPs7. Operation and Calibration SOPs8. Preventive Maintenance SOPs 10
  11. 11. We Offer: Scientific and Technical DiscussionsWe tackle your scientific and technical queries pertaining toregulatory/ GMP/ Quality compliance: compliance: 16
  12. 12. We Support in: Product and Business DevelopmentWe extend support both the vendors and customers for businessdevelopment through a strategic alliance and agreements. We agreements.support for: for: 17
  13. 13. We Offer: Online ConsultancyOur company is the in India to bebased entirely on the Internet. We work closely with experienced and highly skilledprofessional 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 tospend 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 youneed it. We specialize in conducting GMP and quality reviews in both English and locallanguages for batch records, annual product reviews, investigations, complaints anddeviations, etc. We can also assist you in the creation of documentation such as master batchrecords and standard operating procedures (SOPs).We also provide key pharmaceutical document templates such as SOPs, master plans andtraining modules to support your daily cGMP affairs. What’s more, as an Internet-basedconsultancy, we don’t generate costly travel and hotel expenses. Instead, we focus entirely onthe task in hand – providing you and your company with precisely the advice ordocumentation you need in the most cost-effective manner. 18
  14. 14. 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: 19
  15. 15. Our Esteemed CustomersWe have customers in various pharmaceutical fields in India and overseas to whomwe are providing our value added services on continuous basis. Our Indian customers:1. Titan Laboratories Private Limited 23. Amoli Organics Pvt Ltd2. Titan Pharma Pvt Limited 24. UBM India Limited3. Nivika Chemo Pharma Private Limited 25. Anamayee Pharmachem Pvt Ltd4. Suchem Laboratories5. Suleshvari Pharma6. Dolphin Chem7. Anuh Pharma Limited8. Orex Pharma Private Limited9. Apex Healthcare Limited10. Great Pacific Export Limited11. Anan Drugs and Chem Limited12. Annamalai University13. Gujarat University14. Asia Business Forum15. IBC(Asia)16. Parul Institute of Pharmacy17. Isomatric Health Care Limited18. Adani Pharmachem Private Limited19. Benzo Petro International Limited ( Arch Pharmalabs Limited)20. SICART21. Zephyr Synthesis Private Limited22. Rubamin Limited(Pharma Division)***In addition to India, we have customers in South Asian countries and other parts of the world. 20
  16. 16. Contact us for business association J.RAMNIWAS ( Founder and CEO) 21

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