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Sai pharma solutions inc a gateway of regulatory affairs,quality managment and gmp compliance-1
SAI PHARMA SOLUTIONS INC.We Offer : Online ConsultancyOur 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 tobenefit 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 you need it. We specialize inconducting 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 asmaster batch records and standard operating procedures (SOPs).We also provide key pharmaceutical document templates such as SOPs, master plans and training modules tosupport your daily cGMP affairs. What’s more, as an Internet-based consultancy, we don’t generate costly travel andhotel expenses. Instead, we focus entirely on the task in hand – providing you and your company with precisely the SAIadvice 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: firstname.lastname@example.org Phone No: +919558809128, Website: www.saipharmasolutions.com
SAI PHARMA SOLUTIONS INC. SAI PHARMA SOLUTIONS INC.Introduction We Offer : Training and We Offer : DocumentationSai 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 RequirementOur Vision • Pharmaceutical Educational Institutes • Master Production and Control Record(MPCR) • On Job trainingPreparing Pharmaceutical Industries/Institutes for Global Regulatory Compliance by education, training, auditing, • Batch Production and Control Record(BPCR) • Training to Departmental heads to certify asdocumentation and regulatory submissions by way of generating awareness among the pharmaceutical entrepreneurs • Validation Activities( Process Validation, Cleaning internal trainerregarding the future course of the regulatory mechanism and increasing customers expectations consequential technical up Validation, Analytical Method Validation etc.) • Specialize training for QC, QA & Manufacturinggradation 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 whileOur 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 trainers2. 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 Documentation3. 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 document6. 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 toPharmaceutical Manufacturers 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 GMPRegulatory 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 SupportRequirements. 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 diligenceOur 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”