Biovance Consulting

Worldwide Regulatory and Quality Consulting for Pharmaceutical, Medical Devices and Supplement Industries.  We can assist clients (both large and small) in regulatory strategy, preparation of FDA submissions, product manufacturing and testing, biocompatibility, software, clinical trial design and evaluation, and QSR regulatory compliance. We offer consulting services and regulatory support based on a full understanding of FDA regulatory expectations and policies.

Our firm is comprised of senior and executive level professionals led by Dr. Diane Sudduth, MS, DVM, MAPST, MPH with the expertise necessary to help you solve the critical challenges facing your organization, led by a former FDA/USDA medical reviewer, who also has 20+ years of industry experience. 

Our professionals have spent an average of 18 years working within the industries we serve in both line and corporate management capacities.  We are experts in regulatory affairs, quality assurance, compliance, operations, manufacturing, validation, information technology and human resources. 

Need assistance in complying with FDA regulations or individual projects requiring specific expertise?  We are experts in US FDA and international regulatory requirements.

With expertise in:

  • US FDA, Canada and EU regulatory submissions
  • Risk Management
  • Establishment Registration and Listings
  • Validations, and
  • Quality System Implementations

We bring you proven expertise.  Consider us as an extension of your team supplementing your company’s resources to provide expertise in critical areas.

 

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