Regulatory Strategy and Global Filings

Regulatory Strategy 

Our experienced staff helps clients design regulatory strategies that can trim months and dollars off product development paths. We are adept at mapping client’s business strategy, risk tolerance, and budget to the proper regulatory path. Pearl Pathways can also design a logical and clever global registration plan that allows you to maximize re-use of critical clinical, non-clinical, CMC, and product engineering and testing data globally.

Regulatory Filings

We expertly negotiate global health authorities’ interactions and filings so that pharmaceutical and biologics, diagnostics, devices are one the market as quickly as possible. Our team has broad expertise across all spectrums of the regulatory requirements including clinical, non-clinical, CMC, Design Controls, 21 CFR Part 11, and the nuances of companion diagnostics.

Our team also has the expertise to format, compile, publish, and submit your bio-pharmaceutical regulatory submission electronically through FDA’s Electronic Submissions Gateway (ESG) using the eCTD format.  Additionally, we are adept at the required eCopy format for 510k and PMA medical devices.

Types of filings:

  • 505 (b)(2), ANDA
  • IDE, CE Mark, 510k, PMA
  • Orphan drug and device designation
  • Fast track designations
  • Expanded Access/Compassionate Use
  • And many other countries requiring a Certificate of Origin
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