TheRAssist, led by Shoshie Katz is providing comprehensive Regulatory and Quality Assurance support and consultation over the entire lifecycle of product development, from the earliest stages of company start-up through regulatory approval and marketing of new products.


Regulatory services include preparation of regulatory strategy, project management and assessment documents for the development program, including due diligence assessments, briefing packages for meeting with regulatory authorities as well as management of these meetings, involvement in clinical trial design and preparation of clinical documents, IND/NDA/BLA/MAA preparation, review of pre-clinical study protocols and reports, meetings with Health Authorities, and strategic consultation. 
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Quality Assurance services include establishment, implementation and verification of end-to-end quality system including change control, documentation control, investigation of deviations and out of specifications and effective corrective and preventive action (CAPA) system, vendor qualification and vendor quality oversight, batch review and release, risk management, complaints reporting system and training.
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