Regulatory Dossiers Burton, 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, decentralised and centralised 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

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

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