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- And when on-site visits aren't feasible, our flexible shipping model makes it possible for us to guarantee business continuity and the lowest probable effect on all auditing functions, we accomplish audits remotely by means of documentation reviews and SME conversations According to Pharmexpert methodology. And When onsite audit feasible, We strategy for onsite audit.
Performing from the First growth exercise phase, applicant range, by means of scale up and technical transfer in the manufacturing facility network, our abilities in validation and microbial assessment of the manufacturing approach, threat assessments and scientific trial styles may be priceless when applied to your portfolio.
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Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting organizations with marketplace authorities expert in complexities of the pharmaceutical and biopharmaceutical industries.
Constructing over a prosperous background of building AI for healthcare, IQVIA AI connects the proper info, technological know-how, and know-how to address the distinctive desires of healthcare. It is really what we phone Health care-grade AI.
Our GMP/GxP professionals maintain you to the Protected facet. We provide Specialist help inside the implementation of GxP-compliant quality administration programs.
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We leverage State-of-the-art know-how and a robust Make contact with network to rent talent that can add new Proportions to your company.
Regulatory Compliance Associates pharma regulatory consultants will build a comprehensive proof e-book of documented proof demonstrating the corrective action taken to remediate non-compliant difficulties.
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