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Sai pharma solutions regulatory and quality management service providers -introductory letter


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Pharmaceutical Regulatory Affairs, Quality Managment and GMP Compliance Services

Pharmaceutical Regulatory Affairs, Quality Managment and GMP Compliance Services

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  • 1. Dear Sir/Madam;Greetings from Sai Pharma Solutions Inc.!We take pleasure to introduce ourselves as M/s. Sai Pharma Solutions Inc playing a pivotal rolein the world of Pharmaceuticals. We are one of the leading Regulatory and Quality ManagementService Providers and Consultants of India since 2008. Our core activity is preparation ofDMF/Dossiers/CTD/COS/SOPs/BPCRs and all GMP documents. We provide ComprehensiveSolution for Preparation, Filing and Registration & Updates of Drug Master Files (DMF) for API& Registration Dossiers for Formulations at a single contact point.QUALITY MANAGEMENT AND GMP COMPLIANCE SERVICES:NEW MANUFACTURING FACILITY :SAI PHARMA SOLUTIONS INC. provides support on setting up of a new pharmaceutical ormedical device manufacturing facility. Our support covers Design, Construction, Adaptation ofbuilding, HVAC System, Documentation, Training, Validation and Qualification; Approvals bythe National and International regulatory agencies.EXISTING PREMISES: EXTENSION, MODIFICATION:Organizations facing a problem in complying with revised Schedule M, WHO-GMP, USFDA,PMDA, Japan, Health Canada, ASEAN-GMP, EU-GMP or looking for expansion may seek oursupport. We provide them with a revised building layout and HVAC system, Water system andBuilding and Facility Construction Requirements as per guidelines. Cost effective solutions areprovided in respect of Building & Documentation. Internal Audit, Qualification and Validationactivities are also undertaken simultaneously.TURN KEY PROJECTS :SAI PHARMA SOLUTIONS INC. also offers consultancy for projects on turnkey basis. Thetechnical support covers aspects of Land Selection, Estimates, Building Designing; Selection forContractors for Civil work, Air Handling Systems, Electrical and Plumbing Work, Supervisionof Construction, Equipment Selection; Validation and Qualification; Selection of Personnel andtheir training; Documentation; Initiation and Operation of plant; Certification for GMP/ISO9001-2008,ISO-14001SO-18001,ISO-22001/NABL and other international approvals.
  • 2. AUDIT OUTSOURCING :Due to limited man power, at times companies are not able to effectively conduct audit of theirvendors/suppliers. SAI PHARMA SOLUTIONS INC. offers audit support to companies whowould like to outsource this task.DOCUMENTATION:Documentation is an essential part of Quality Assurance and hence shall cover all aspects ofGMP. Good documentation helps in operation of plant smoothly. SAI PHARMA SOLUTIONSINC. provides support in developing complete documentation such as Quality Policy, QualityManual & Objectives, Site Master File, Procedures, Specifications, Drugs Master File, SOPs,STPs, Guidelines, Environment Monitoring, Drawings, Flow Charts, BMRs, Formats & DataSheets. Documentation also includes Document Distribution & Control, Review System, ChangeControl System, Recall, Complaint Handling, Non-Compliance & Non-Conformities. Theemployees are guided to prepare documents on their own.CLIENT-SITE TRAINING :SAI PHARMA SOLUTIONS INC. also conducts training courses, tailored to meet precise needsof the client. For this purpose, we use basic principles of dynamic instruction. Client-site trainingprogramme is a cost effective way of training higher number of personnel. An on-siteprofessional faculty with the required expertise is provided. The participants are not only madefamiliar with the selected subjects but also get an opportunity to discuss their technical issues.TECHNICAL AND SCIENTIFIC ADVISORY SERVICES:We are also technical and scientific advisors for many companies to support in all issuespertaining to Quality Management and GMP compliance due to fast changing of guidelines andrequirements.REGULATORY AFFAIRS COMPLIANCE SERVICES:ADVISORY SERVICES:The regulatory affairs team at Sai Pharma Solutions Inc. assists you in navigating through theregulatory submissions & management process, developing your registration strategy andhelping you in submissions management. Our regulatory affairs team works alongside our
  • 3. clinical and safety experts to author and compile dossiers, in part or in whole, and also to publishand maintain the dossiers. Our advisory services include but not limited to: • Global registration strategy • Interactions with regulatory agencies in emerging markets • Identification of deficiencies in submissions • Training and audit preparednessSUBMISSION MANAGEMENT:We can advise and help you formulate regulatory and submission strategies across variousmarkets. Our submission management includes but not limited to: • Regulatory briefing packages and submissions • Annual reports (labeling, stability, distribution and CMC changes) • Dossiers (in CTD, eCTD and ACTD format or country-specific format) • Supplements, amendments and variations • Responses to deficiency queries • Maintenance of labels and reference safety informationREPORT AUTHORING:We help you maintain compliance after your product secures approval, through its entirelifecycle, by authoring amendments, variations, annual reports and post approval regulatory auditresponses. Our regulatory affairs team authors specific CMC reports across all the modules ofthe dossier which includes but not limited to: • Quality Overall Summary (QOS) • Clinical and non-clinical overviews • Product Quality reports • Analytical method validation and process development reports • Stability reports • Labeling - pack shots and pack inserts • Site Master File [SMF]Contact us and identify how we can help you in approval and compliance.Should you have further queries & any assistance needed from our side, please feel free tocontact us anytime.
  • 4. Thanking you and best regardsJ.RAMNIWASFounder & CEOSAI PHARMA SOLUTIONS INC.(Gateway to Regulatory Affairs, Quality & cGMP Compliance)102,Shraddha Saburi,Narayan Gardens, VUDA Road, Gotri -390021Vadodara (Gujarat) IndiaEmail: jramniwas@saipharmasolutions.comPhone No: +919558809128Website: www.saipharmasolutions.comOur Motto" Start to finish, everything in between".