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Regulatory Solutions


Regulatory Solutions

Regulatory Affairs professionals usually have responsibility for the following general areas:
  • Ensuring that their companies comply with all of the regulations and laws pertaining to their business.
  • Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
  • Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.


BEQS can provide services related to the following:
  • 510K/PMA
  • Site Registration
  • Device Registration
  • FDA 483 and Warning Letter Responses
  • Strategic Solutions for FDA 483, Warning Letters, Consent Decree, Import Alerts etc.
 
  


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