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Global Regulatory and Submission Experts Offering Over 30 Years of Insight
For overdecades, this international consulting firm has provided strategic guidance and deliverables to support clients through the entire drug development process - from preclinical to clinical trials, data analysis, regulatory submissions and more. With expertise spanning numerous therapeutic areas, they offer comprehensive contract research and submission services including CDISC conversion, eCTD publishing and US agent representation. Their consulting integrates evaluations across nonclinical, clinical and CMC disciplines to identify development gaps and regulatory strategies. Services range from trial design, pharmacology reviews, dataset coding, IND/NDA authoring, FDA briefing books, due diligence and beyond.
Global Regulatory and Submission Experts Offering Over 30 Years of Insight
For overdecades, this international consulting firm has provided strategic guidance and deliverables to support clients through the entire drug development process - from preclinical to clinical trials, data analysis, regulatory submissions and more. With expertise spanning numerous therapeutic areas, they offer comprehensive contract research and submission services including CDISC conversion, eCTD publishing and US agent representation. Their consulting integrates evaluations across nonclinical, clinical and CMC disciplines to identify development gaps and regulatory strategies. Services range from trial design, pharmacology reviews, dataset coding, IND/NDA authoring, FDA briefing books, due diligence and beyond.
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