RedLotus Pharmtech Pvt. Ltd.
Pharmaceuticals - Navi Mumbai, Maharashtra, India
RedLotus Pharmtech Pvt. Ltd. Employees
RedLotus Pharmtech Pvt. Ltd. Senior Management
RedLotus Pharmtech Pvt. Ltd. Details
Along with our identified and qualified associates and partners RedLotus, "Pharma Technical Services" brings in years of collective experience in the areas of a drug substance as well as a drug product development, analytical method development & transfer, technology transfer, manufacturing, quality assurance & control, regulatory affairs, pharmaceutical engineering qualification & validation and supply chain.Our Services:QA & GMP Compliance: (a) QMS – Design & Effectiveness, (b) GMP Audit – Vendor, Services, Mock Inspections, DI, Sterility Assurance, (c) GMP Risk – Analysis & Mitigation, (d) Training – GMP, QMS, DI, Sterility Assurance.Regulatory: (a) Filing Document – Preparation and Review, (b) Compliance – Response Strategy, Preparation, Review, Issue Resolution & Remediation.Technical Due Diligence: (a) Assessment of Target – Hardware, Software, People & Operations (b) Gap Analysis, (c) Assessment of Systems & Controls – Management Controls and Personnel CapabilitiesQualification and Validation: (d) Development – Q. Policies, Strategy, VMP, Q&V Protocols & Reports, Sterility Assurance, CV, CSV, PV, Sterilization, Media Fill, Analytical Methods, (e) Reviews and Gap Analysis – Compliance, Suitability & Adequacy, Sterility Assurance, Media Fills, Trend Analysis, Statistical Process Analysis, APQR, (f) Guidance & Training – Q&V, Sterility Assurance, Media Fills, Aseptic Manufacturing, (g) Investigations – FI, Guidance, Reporting, Review, CAPA & Position PapersTraining: (a) General & Bespoke – GMP, Q&V, QMS, CI, Sterility Assurance, Sterilization.Design & Engineering: (a) Development – Concept Design, URS, FAT, PMP, Calibration Plan, (b) Review and Gap Analysis – Facility/ Equipment Design & Spec, PMP, Calibration Plan.Mentoring & Advisory: (a) Manufacturing Philosophy & Strategies, (b) Advisory & mentor role, (c) Mentor teams/ individuals, (d) Project reviews and management, (e) Strategy for setting-up pharmaceutical business, (f) Operation Excellence
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