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Aptuit Consulting Inc
Regulation Strategy

Regulatory Strategy & Support Services

Aptuit Consulting’s experts are knowledgeable in the FDA, EMA and HPFB regulatory requirements.  Our Regulatory-support services include:

  • Experienced US and EU Regulatory professionals with proven track records of success with US and EU Regulatory Authorities.
  • Development and successful execution of world-wide Regulatory strategies for small molecules, biologics, medical devices and advanced therapies.
  • Strong technical expertise to support CMC, Pharm/Tox and Clinical submissions.
    Writing, publishing and submission of US and EU Regulatory documents including INDs, IMPDs, CTA’s, NDAs, BLAs, 510k’s and PMA.
  • ePublishing and submission services
  • US Agent services for non-US companies
  • EU Legal Representative services for non-EU companies
  • Regulatory authority liaison and meetings