Regulatory Delivery
Regulatory delivery at PrimeRA covers the full arc of submission and procedural work, from the first CTA or IND through to Marketing Authorisation, executed by a team with direct experience across the most complex ATMP programmes approved in the UK, EU and US. For companies managing a global development strategy, PrimeRA aligns UK, EU and US regulatory activity from the outset, protecting timelines across jurisdictions and ensuring the programme builds toward its commercial goals without costly rework. Our Delivery pillar works in close coordination with our Leadership pillar, which provides the strategic direction that guides execution.
Regulatory execution across the full development arc
Delivery at PrimeRA covers the full range of regulatory execution - preparing, writing, reviewing and leading all procedures from initial pre-submission meeting packages through to Marketing Authorisation dossiers. The team integrates with the client's scientists and internal contributors at the depth the programme requires, filling resource gaps at any scale, and keeping key deliverables on track.
Two services form the structural backbone of how PrimeRA plans and manages delivery. The bespoke regulatory roadmap is a working planning document that places every regulatory milestone - submissions, agency meetings, designations - in the context of data generation timelines, giving leadership and investors a transparent view of dependencies, critical path decisions and what each milestone requires. The Regulatory Advisory Board service allows PrimeRA to contribute to or lead the formation of a client's RAB - hand-selecting consultants with the relevant modality and discipline expertise, preparing materials that frame questions with precision, and consolidating outputs into guidance that integrates directly into programme planning.
From first submission to first-in-human
PrimeRA prepares and leads the regulatory procedures required to move a programme into clinical development. This includes drafting and compiling IND and CTA applications, authoring the IMPD and Module 3, and building the meeting packages that establish the programme's regulatory position with the agency before a submission is filed. The team manages all agency interactions, ensuring positions are precisely framed, questions are anticipated and responses are coordinated without delay.
Accelerated pathway applications are a core component of clinical stage delivery. Orphan Designation (EU and US), PRIME, ILAP, Fast Track, Breakthrough Therapy, RMAT and RPDD each require tailored applications that draw on the clinical and scientific evidence package in ways that align precisely with the specific designation criteria. PrimeRA prepares these applications, advises on sequencing and timing to maximise the benefits obtained, and manages the agency interactions that follow.
End-to-end delivery through to authorisation
Marketing Authorisation is the most demanding regulatory procedure in drug development. The quality of the dossier, the coherence of the regulatory position and the management of the agency relationship all carry the greatest weight at this stage. PrimeRA takes full ownership of MAA and BLA delivery: authoring and reviewing all dossier sections, coordinating the submission procedure, managing Rapporteur and agency engagement throughout the evaluation, and preparing responses to questions across regulatory, CMC, non-clinical and clinical disciplines.
A Paediatric Investigational Plan is a mandatory regulatory requirement under EMA regulation, and paediatric strategy - including timing and the scope of the paediatric programme - is a consideration that should be resolved well before the MAA stage. PrimeRA prepares PIPs and manages the EMA negotiation process. For programmes with a US development path, PrimeRA also prepares the FDA Pediatric Study Plan (iPSP) — the US equivalent of the PIP. The bespoke regulatory roadmap is available at this stage, placing MAA filing, Rapporteur timelines and post-authorisation milestones in the context of data generation and the commercial decisions that depend on them.
A track record built on programmes that changed the field
Our team have contributed to the development, commercialisation and maintenance of numerous approved ATMPs including CAR-Ts, AAV, CRISPR and HSPC derived products.
PrimeRA has worked across AAV, Adenovirus and Lentivirus vectors; T-cell, HSPC and iPSC cell types; and gene editing techniques including CRISPR and Base Editing. This modality depth informs how PrimeRA evaluates regulatory pathways - including platform approaches and cross-modality strategies - to identify the most efficient route to approval for each programme.
Every engagement is structured around what the programme needs - integrating with the client's scientific team at the depth the programme needs, stepping in at any point in the development arc, and scaling resource as milestones approach. The aim is consistent: protecting timelines and keeping deliverables on track.
From first submission to authorisation
Delivery covers the preparation, authoring and procedural execution of regulatory documents and submissions across the full development arc - from IND and CTA through to MAA and BLA, including designations, agency meetings and response work. Strategic direction and senior regulatory oversight sit under the Leadership pillar, which shapes the position and approach that Delivery executes.