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