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| Some of our projects |
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Regulatory Submissions |
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FDA - US INDs; briefing packages |
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EU CTAs; IMPDs |
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TPD - Canadian CTAs; QOS |
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Drugs Controller India - INDs ; clinical trial applications |
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Regulatory compliance |
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Systems review/audits |
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Establishment of systems and procedures |
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GMP,GLP, GCP |
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Regulatory strategy |
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Drug development |
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Clinical research |
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Interface with regulatory agencies |
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Technical consulting |
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Manufacturing -Site/vendor evaluations; GMP audit |
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Documentation |
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SOPs, guidelines, reports, summaries |
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Customized training programs |
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Industry-specific |
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Academia-oriented |
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