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You are here:The Infection Prevention Strategy/Regulatory Affairs

Regulatory Affairs

Our team is ready to help you define a road map to success. Utilizing our partner network we can quickly establish the path, direction and team required to achieve certification and compliance in the United States and Canada.

Services Include

  • Regulatory Affairs & Quality Systems-Keeping Companies Globally Compliant
  • Medical Device and Pharmaceutical Regulatory Strategies
  • Regulatory Strategy Development
  • EPA Alternative Test Procedures
  • Submission Preparation
  • Regulatory Agency Interactions
  • Chemistry, Manufacturing and Controls
  • FDA
  • Health Canada
  • Multiple Industries: Pharmaceutical, Medical Device, Food, Agriculture, Healthcare, Commercial

Partners

NSF International NSF International (nsf.org) is a global independent organization that writes standards, and tests and certifies products for the health sciences, water, food, and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 170 countries, NSF International is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.
 The University of Arizona ESRAC The University of Arizona ESRAC’s mission is to provide expertise to industry, the community, and researchers in the areas of human exposure science and risk assessment of chemical, biological and physical hazards to workers and communities, with an emphasis on healthcare-acquired infections. The approach promotes viewing environmental exposures in the context of human health and safety through hazard identification, monitoring and modeling of exposures, health effects and risks, intervention, mitigation and economic impact of these exposures.
CremCo Our global Innovation partner CREM Co (cremco.ca) is licensed to work with Risk-Group 2 human pathogens and toxins under Section 18 of the Human Pathogens and Toxins Act and Risk-Group 2 terrestrial animal pathogens permit under Section 160 of the health of animals regulations in EPA-regulated testing facilities.;
Network Partners Network Partners provides packaging engineering, labeling, cold chain and regulatory affairs resources to Medical Device and Pharmaceutical companies.  Whether it’s a packaging design & development project, validation testing, or meeting regulatory compliance requirements - our network of subject matter experts create customized consulting solutions for clients.

 


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