Obtaining, holding and maintaining a Marketing Authorisation requires an expert Regulatory input to ensure compliance and the most effective and efficient route to market. As a Marketing Authorisation Holder, your licence is a valuable asset and we can help you obtain, protect and maintain that asset throughout the product lifecycle.
Our team are highly experienced in the regulatory requirements associated with the UK and European regulatory bodies for human, veterinary and herbal medicines and can support all areas of the regulatory process.
OUR TAILORED SERVICES CAN INCLUDE:
Preparation of regulatory dossiers for the UK, Europe and other markets
Preparation of applications in vNeeS and eCTD format and ‘Due diligence of dossiers’
Management of national, EU mutual recognition and decentralised licensing
Life cycle management including all types of variations, renewals and Change of Ownership applications
Preparation of SmPCs, labelling and leaflets and PIQU submissions
Reclassification and Sunset Clause applications
Liaison with Regulatory Authorities including attendance at Scientific Advice Meetings
With many years of experience liaising with, and submitting to Competent Authorities and Regulatory bodies, particularly in the UK and across Europe, we can offer practical advice as to the best strategies to adopt for successful applications.
If you have a current product portfolio, are looking to build a portfolio or simply to move your products into different market jurisdictions we can assist you to navigate the regulatory requirements.
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If you would like to find out more about any of our services please fill out the form below. We would love to here from you.