callisto consulting uk regulatory solutions    callisto consulting    regulatory services uk    regulatory service uk    regulatory affairs uk   

 
 

 
 
 

 

 
 
 
 

.Regulatory.Services.

For all your regulatory affairs requirements including:

  • Preparation of regulatory dossiers for the UK, Europe and other markets.

  • Management of EU mutual recognition and centralised licensing.

  • Preparation and signature of Quality Overall Summaries, Nonclinical and Clinical Overviews.

  • Preparation or reformatting of DMF’s into CTD format.

  • Licence maintenance including variations, renewals, PSUR’s and pharmacovigilance.

  • Advice on and preparation of SPC’s, labelling and leaflets.

  • Change in legal status applications.

  • Liaison with Regulatory Authorities

   

We can help you maximise the potential benefits to your company of the Traditional Herbal Medicinal Products Directive:

  • Strategic advice on how Directive 2001/83/EC affects the products you currently market.
 
 
 
 

home    |    regulatory services    |    technical support    |   contact us

  
 

Facilities, descriptions, details & prices correct at time of publication.  For up to date information please contact us.  Copyright © 2004 - 08 JWP