Regulatory Representation
Across the US, UK and EU
Regulatory engagement with the FDA, MHRA and EMA requires an authorised presence in each jurisdiction before a single submission is made. PrimeRA holds designated representation across all three markets, acting as your named point of contact with each agency under a fixed monthly retainer.
A legal prerequisite, not an administrative step
Representation is a statutory requirement that must be in place before formal regulatory submissions are made and clinical or commercial activities begin. For formal filings such as CTAs, INDs and MAAs, the FDA, EMA and MHRA each require a designated, in-jurisdiction representative. Certain pre-submission interactions - including scientific advice and specific early access or designation routes - may proceed without a representative in place, but the requirement applies to all substantive submissions. It applies regardless of programme stage or company size.
For early-stage ATMP developers, academic spinouts and international companies entering the EU, UK or US market for the first time, establishing that presence is among the first and most important steps in any regulatory programme. PrimeRA provides that presence through a team with direct experience of the agency landscape you are navigating.
Scientific advice, ILAP, PIP and PIM/EAMS do not require UK representative designation.
US Agent
Any foreign sponsor seeking to engage the FDA - whether through an IND, NDA, BLA or pre-submission meeting - is required to designate a US Agent. PrimeRA acts as that named contact: receiving agency correspondence, managing communication timelines.
Our team supports every interaction, flags what requires action and by when, and coordinates with your internal team to ensure regulatory continuity.
EU Representative
Non-EU sponsors submitting a Clinical Trial Application or Marketing Authorisation Application must appoint an EU Representative established within the Union. PrimeRA holds that designation, providing a legally compliant point of contact with the EMA and national competent authorities across member states.
From PRIME designation through to MAA, we remain your single named representative, ensuring continuity, regulatory credibility, and a responsive interface with the agency.
UK Representative
Post-Brexit, the UK operates its own regulatory framework for clinical trials and medicines, with the MHRA acting independently of the EMA. Non-UK sponsors submitting a Clinical Trial Authorisation or seeking a marketing authorisation are required to appoint a UK-established representative as the legal point of contact for that procedure.
PrimeRA holds UK representation as a standalone service or as part of a dual UK/EU mandate, providing a single point of continuity across both jurisdictions where development strategies span both markets.
Representation that works alongside your strategy
Our team brings deep experience in ATMPs, rare diseases and complex biologics. Representation with PrimeRA is informed by experience and an understanding of the science and pain points ahead.
For developers managing both designations and regulatory consultancy needs, consolidating these with a single partner removes the complexity of coordinating mulitple providers and ensures consistent positioning with each agency.
We interpret every item of agency correspondence in the context of your programme. Whether you have in-house regulatory expertise or require broader strategic support when engaging agencies, that understanding shapes every interaction.
What's included — and what's not
The retainer covers all representation obligations. Work that goes beyond designation - such as submission authoring or strategic advisory - is scoped separately under our Delivery and Strategy & Insight pillars.