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 & Strategies, (b) Advisory & mentor role, (c) Mentor teams/ individuals, (d) Project reviews and management, (e) Strategy for setting-up pharmaceutical business, (f) Operation Excellence