Market Authorisation

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.

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.

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.

Need an applicant in the UK or Europe for your new procedure? Look no further.