What does Redlotus Pharmtech Pvt. Ltd. Do ?
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 capabilities qualification 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 papers training: (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 and strategies, (b) advisory & mentor role, (c) mentor teams/ individuals, (d) project reviews and management, (e) strategy for setting-up pharmaceutical business, (f) oe