Regulatory Submission Services

Your partner in FDA regulatory submissions, Accorto will streamline the process to get you to market quickly and efficiently.

Regulatory Submission Services

Your partner in FDA regulatory submissions, Accorto will streamline the process to get you to market quickly and efficiently.

Turnkey Regulatory Submission Solutions

Let our team take the complexity out of FDA regulatory submissions. Our team has decades of experience navigating the intricate FDA regulatory landscape across a variety of regulated industries, allowing us to seamlessly guide your product through the appropriate pathway towards market acceptance. From strategy development to application submission, we’re your partners in securing swift approvals and market leadership.

Our submission services include:

  • Application Strategy Development
  • Regulatory Pathway Identification
  • FDA Pre-Submission Meetings
  • Ongoing Agency Communication
  • Gap Assessment
  • Document Collection and Development
  • Clinical Studies & Analytical Testing

  • Publishing

  • Application Submission

  • Deficiency Letter Remediation 

  • MDO Response Strategy

Industry Focus

Our team has streamlined our processes to develop bespoke regulatory submission solutions for our clients in the medical, biotechnology, diagnostics, pharmaceutical, cosmetics, and nicotine industries. Our team supports the following applications:

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to learn how our team can streamline your path to market today.

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