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, 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 issues noted:
- 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.
