Market Authorisation Holding
Application Service for Marketing Authorisation Application (MAA)
Are you in need of someone to act as an applicant in the UK and in the European Union for your medical licence applications?
All medicinal products are required to obtain a marketing authorisation (MA) before they can be placed on the market. MA applications come with considerable time and cost associated, so it is key that they are in a safe pair of hands whilst the application takes place.
PDS can act as applicant for your MAA procedure in the UK or Europe. Our team in Europe together with our team here in the UK with help you ensure your MAs get safely approved.
The MA will certify that the product meets all the requirement standards of safety, quality and efficacy.There are four routes to gaining the EU currently:
• Centralised Procedure (CP)
• Mutual Recognition Procedure (MRP)
• National Procedure
• Decentralised Procedure (DCP)
Having had many years of experience across all four routes to market, we here at PDS can provide regulatory support and guidance throughout the applications lifespan, you can be assured that we will continue to work hard to ensure it stays there.
Here at PDS we can create eCTDs for new applications as well as convert dossiers in part or whole for older MA applications and variations, renewal applications, reclassification of medicines and Periodic Safety Update Reports (PSURs) to ensure that your product continues to meet the necessary standards of safety, efficacy and quality.
PDS and is an SME company so can benefit from fee reductions and deferrals. Post Brexit our partner company can act as an SME in the EU.
Call us now on +44(0) 1476 512395 to discuss your project with one of our team.
Need an applicant in the UK or Europe for your new procedure, look no further? Let’s work together to get your product to market. Here at PDS you are always safe in our hands.