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Regulatory Support

Regulatory Affairs Support

Through its dedicated regulatory affairs department, Skyepharma offers a broad range of regulatory services and project management assistance to support its partners in obtaining and maintaining approvals from authorities, a key factor for the success of our collaboration.

We assist our clients in preparing their submissions, for product maintenance processes and advise on regulatory strategies, such as for:

  • NDA / ANDA / EU-Marketing Authorization Application writing,
  • Supplement / variation writing and other lifecycle management activities,
  • Answers to health authorities’ inquiries and periodic registrations,
  • Proactive regulatory intelligence monitoring.

Skyepharma regulatory affairs department is experienced in assisting on projects of all kind of products (health/dietary), markets and specificities.

The facility is EU GMP certified and FDA registered for development & manufacturing with extensive experience in US and EU regulatory filings in collaboration with pharmaceutical companies of all sizes.

We have a constant track-record of passing inspections, with no major nor critical issue observed:

  • FDA approved since 1998
  • ANVISA approved since 2013
  • Registered at Korean MFDS since 2012
  • EU GMP certified facility

Skyepharma facility has a consistent history of regulatory approvals for development, manufacturing and packaging of pharmaceutical products for European, North & South American and Asian markets.