Therassist Ltd

TheRAssist LTD. is a consulting company, providing Regulatory and Quality Assurance support and consultation over the entire lifecycle of product development. Regulatory services include preparation of regulatory strategy and assessment documents, including project management and 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 non-clinical study protocols and reports, due diligence, meetings with Health Authorities and Key Opinion Leaders, strategic decisions, and more. Quality 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 CAPA system, vendor qualification and vendor quality oversight, batch release, risk management, complaints reporting system, training, and more.