Eunaris

We manage your European Authorisations

Eunaris is our sister concern, headquartered in London. Through this company, we provide support services to various authorisations like MA, MIA, WDA, etc.

 
 

Regulatory Support

We provide regulatory support services for your EU Market authorisations in accordance to Article 23 of Directive 2001/83/EC and Annex 1 to Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004.

 

The services include, but not limited to the following:

  • Filing "Change of Ownership" for MAs.

  • Filing all types of Variations for your existing MAs, MIA, WDA.

  • Maintaining & updating the eCTD baseline documents for all your licenses.

  • Updating PSURs.

  • Artwork preparations.

  • User testing for Product Information Leaflet (PIL).

  • Renewal applications.

  • Conversion of your existing dossiers into eCTD dossiers.

  • New product development and preparation eCTD dossiers for the EU, Australia and the US.

Pharmacovigilance support

We also provide PV support services in accordance to Regulation (EC) No 726/2004 and Directive 2001/83/EC.

New Applications

If you are looking for obtaining Market Authorisation (MA), Manufacturing & Importation Authorisation (MIA) or Wholesale Distributor Authorisation (WDA) in the UK or the wider EEA, we can help you in that.

We can provide comprehensive support services ranging from New Product Development, Bio-equivalence studies, Stability testing, preparation of eCTD dossiers (as per Annex 1 to Directive 2001/83/EC), and apply for new Market Authorisation, through various procedures like,

  • Centralised Procedure

  • Decentralised Procedure (DCP)

  • Mutual Recognition Procedure (MRP)

Third-party site audits

If your company is holding an MA, MIA, WDA or PI license, we can conduct third-party audits on behalf of your company inside the UK and the wider European member states and submit an audit report.

 

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