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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, we support them during 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.

Skyepharma quality team