Edgewater Regulatory Solutions prides itself on delivering high quality regulatory documents on time and on budget. With over 7 years of nonclinical and regulatory document experience, we have the expertise to guide you through the regulatory process.
September Mihaly, PhD, RAC, is the President and Principal Medical Writer of Edgewater Regulatory Solutions. In addition to her years of regulatory writing experience, she holds a PhD in Toxicology and a Regulatory Affairs Certification (RAC).
Whether you are working on your first Investigational New Drug or planning to submit final New Drug Applications to multiple agencies, we can help. We can help: from strategy and risk analysis to writing and quality control. Our mission is to reliably and consistently provide solutions, build mutually beneficial relationships, and be there to help answer questions.
We have helped numerous organizations move their drugs and biologics from early stage development, supporting the Investigational New Drug application and New Drug Application or Biologics License Application, and on to market approval.
With over 7 years of experience in early stage regulatory writing and strategy, we have the tools to help build out your drug and biologic applications, manage the document review process, and support your nonclinical programs.
Our services include gap analysis and strategy, regulatory writing and summarization, review process management, and quality control review to support your project through key milestones to submission and market approval.
" These are very well done! As an ex-FDA nonclinical reviewer, the FDA reviewer for this submission will likely appreciate the quality of these documents."
"Your review was valued and the team incorporated most of the suggestions. Nice job!”
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