​In Regulatory/Clinical Consulting, our team of seasoned executives have supported development of clinical and regulatory strategy of more than 50 products for small and mid-sized Pharmaceutical/Biotech companies.

Our 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:

• Submission planning for IND/CTA/ANDA/NDA/BLA/MAA/PMA/510k etc. 
  
• ​Leading submissions
• Slide decks and strategic messaging for Advisory Committees (AdComs)
• Development of Clinical Development Plan (CDP)
• Development of Medical Affairs Strategic Plan
• Slide decks and strategic messaging for Advisory Boards (AdBoards) 

 Documents we have developed:

• Protocols
• Clinical study reports
• Investigator brochures
• Annual reports and updates (DSURs, PSURs etc)
• All Modules (including clinical, nonclinical summaries) of eCTD
• Integrated summaries (Safety: ISS, and efficacy: ISE)
• Abuse liability
• Briefing books
• Agency responses
• Package insert

All our team members have advanced degrees in Science and have led the drug discovery and development programs in academia and industry including multiple therapeutic areas with a combined experience of more than 200 years. Thus, giving us a very strong and thorough knowledge in multiple therapeutic areas to add value to projects we work on.
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For more information on any of our services please reach out to us at:
contactus@viridbiosolutions.com
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