QSI Associates
Pharmaceutical Service Provider and Consulting
Providing customer centric service. Performing supplier qualification audits, mock PAI audits and internal quality system gap analysis. Supporting Pharmaceutical formulation and product/process development (Solid/Liquid Oral, Injectable, Inhalation and Ophthalmics) and CDMO/CRO technical project management. Full spectrum of Regulatory and Pharmacovigilance service.
Our Services
We provide Technical, Quality and Regulatory services that deliver quantifiable results. Our insight and technical expertise combined with our external partners can provide pharmaceutical product/process development, technical transfer, regulatory and pharmacovigilance services, quality systems support and technical trouble shooting.
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Quality Consulting
Our Team of ASQ certified quality auditors CQAs can provide a broad spectrum of Quality Services, from supplier and due diligence audits to internal quality systems gap and failure investigation assessments for your organization. We also have significant expertise with FDA remediation activities, e.g. 483 observation and warning letter responses.
Pharmaceutical Product/ Process Development
From feasibility and development work in our US or our EX US partners' Laboratories, QSI can rapidly move your development program forward with data driven descion points and end game of product prototypes for clinical use. QSI associates will also provide R&D protocol driven experiments, statistical data analysis and FDA submission ready reports.
Pharmaceutical Technical Transfer
Direct Technical and Quality Liaison with the CMO or CRO managing the project for the customer's interest and goals. Reviewing or generating R&D development reports, method of manufacture, raw material and componentry specifications, batch records, stability protocols/report, registration batch protocol/report and reviewing equipment qualifications and process validations,
Regulatory & Pharmacovigilance
Our Regulatory SMEs offer strategic guidance on market authorization (MA) applications lNDA/ANDA, Pre-IND packages, DCP/MRP, and CBE/PAS/Type IA/IB/II, along with eCTD publication and submissions to USA, EU, UK, GCC, authorities and more. We provide end-to-end Pharmacovigilance services, ensuring compliance and patient safety. Partnering with NeoCubes Pharma, we deliver comprehensive support for the Global market.