Innovative Science Solutions (ISS) helps to prepare persuasive regulatory submissions based on sound scientific data. These services include the design and development of INDs, IDEs, 510(k)s, and NDAs in the US as well as CTX, Technical Files and MAAs in Europe. ISS has a global regulatory practice and can also assist in filings with (or the EMA and other EU Health Agencies), Health Canada, and other foreign regulatory bodies.

Some of the more common regulatory services that we are called upon to perform are listed below:

  • 505(b)(2): We have extensive experience identifying when a 505(b)(2) approach is appropriate and developing strategies to maximize successful outcomes.
  • RX-to-OTC Switch: ISS is a leader in pursuing the most challenging, cutting edge RX – OTC switches, and achieves this through a robust understanding of the dynamic between consumers, regulators, investigators, and the medical community.
  • Agency Communication & Meeting Requests: We facilitate communication with FDA several times a month and have our finger on the pulse of changing timelines and dynamics, as well as ensuring that communication occurs through the proper method depending on topic, whether it is a controlled correspondence to quickly clarify a minor point or meeting request to engage in a substantive discussion.
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