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Services / TECHNICAL SUPPORT
​Technical support

​TECHNICAL SUPPORT

We provide flexibility and remarkable adaptation to customers' needs
  • TECHNICAL_METAS_SUPPORT_ALT_LIST01 In-house preparation of DMFs and Technical documentation
  • TECHNICAL_METAS_SUPPORT_ALT_LIST02 Submission of DMFs and CEPs
  • TECHNICAL_METAS_SUPPORT_ALT_LIST03 Preparation of responses to potential Deficiency Letters
  • TECHNICAL_METAS_SUPPORT_ALT_LIST04 Patent and IP support
  • TECHNICAL_METAS_SUPPORT_ALT_LIST05 Technical support
  • TECHNICAL_METAS_SUPPORT_ALT_LIST06 Complex synthesis with large steps
  • Country specific requirements
Country specific requirements
Complex synthesis with large steps

HEALTH AUTHORITY INSPECTIONS

Inke's plant has received periodic inspections from worldwide health authorities with satisfactory results since 2002

FDA Inspection


2016, 2013, 2009, 2005, 2002

Spanish Health Authorities GMP inspection

2017, 2014, 2011, 2008

Korean agency
(KFDA) inspection


2012

Submission of DMFs and CEPs

REGULATORY AFFAIRS

We manage all regulatory aspects on each country from end-to-end
  • Preparation of Drug Master Files for USA, Europe, Japan and Korea
  • Preparation of CEPs (Certificates of Suitability of Monographs of the EP)
  • e-CTD electronic management
  • Customer service: full technical and regulatory support to our customers