Regulatory Dossiers & National Applications

regulatory dossiers and national applications

For all your regulatory affairs requirements including:

  • Preparation of regulatory dossiers for the UK, Europe and other markets
  • Management of EU mutual recognition and decentralised licensing
  • Preparation and signature of Quality Overall Summaries, Nonclinical and Clinical Overviews
  • Preparation or reformatting of DMFs into CTD format
  • Licence maintenance including variations, renewals and Change of Ownership applications
  • Advice on and preparation of SmPCs, labelling and leaflets
  • Reclassification applications
  • Applications for Certificates of Suitability
  • Liaison with Regulatory Authorities
  • Preparation of applications in NeeS format’ and ‘Due diligence of dossiers'

We can help you to 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 that you market
  • Preparation and submission of applications under THMPD

Make An Enquiry:

For any further information please fill out the form below and we will get in touch as soon as possible: