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In Regulatory/Clinical Consulting, ViridBio's team consists of seasoned executives who have supported development of clinical and regulatory strategies of more than 50 products for small and mid-sized Pharmaceutical/Biotech companies. ViridBio's team has developed and/or led 1000s of clinical and regulatory documents across multiple IND/CTA/ANDA/NDA/BLA/MAA/PMA/510k etc. submissions across multiple therapeutic areas. Some of our services include strategic planning and execution of regulatory submissions, and development of all clinical/regulatory documents per agreed timelines, at competitive cost with flexibility to meet stakeholder needs. We bring together and constructively engage Clinical, Pharmacokinetics, Clinical operations, Regulatory affairs, Biostatistics, Data management, Quality assurance, Quality control, and other internal functions and external industry experts to elevate the strategy and execution of assigned task to exceptional levels. Our team follows Client's standard operating procedures, templates, style guides, checklists, document management system to ensure smoother and efficient work flow. |
Our strategic development work includes:
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