An ATMP Clinical Trial Application.
In the EU, UK, and US.
Client type:
Geography:
Lifecycle stage:
Service area:
Summary.
A small US-based biotech startup engaged Arriello to support early-phase regulatory clinical trial submissions for a gene therapy ATMP in the UK, EU and US, as well as regulatory maintenance and local representation for all the clinical trials. The client requested support with:
- Full strategy for early phase clinical trial within the UK, EU and US.
- Submission and maintenance of Phase I/II Proof-of-Concept Study Clinical trial application.
- Expert guidance on ATMP-specific regulatory requirements, lifecycle maintenance, submission, safety and pharmacovigilance reporting, medical writing for IMPD and IB writing, local legal representation, and Pre-IND meeting preparation and attendance.
Challenges.
Global regulatory expertise: The client required regulatory experience and expertise to determine the best strategy for submitting their early phase clinical trial in the UK, EU and US, along with maintenance of the submission when approval was received.
Early Health Authority Interactions: The client wanted to participate in Pre-IND meetings with the FDA and needed support making these submissions and preparing the briefing documents.
ATMP Experience: Due to the nature of the client’s product, ATMPs in all three regions are required to submit additional documentation and information, such as environmental impact assessments, additional training requirements for site and so on.
Combined solutions: The client needed support with both Regulatory and Pharmacovigilance submissions and needed this to be as seamless and harmonious as possible.
Local Legal Representatives: For the UK and EU submissions, a local legal representative needed to be identified who was able to complete activities for both regions from the EU, and in the case of the US, a US-based representative supported with submissions for central/local IRB submissions.
Solution.
Arriello assembled a dedicated global regulatory team with strong ATMP and regional expertise to manage submissions across the UK, EU and US.
We were able to apply our extensive regulatory expertise:
- Providing a tailored briefing document outlined key regional differences in processes, documentation, timelines and RFIs, enabling early preparation and mitigating submission risk.
- Supporting with medical writing and regulatory experts, preparing high-quality IMPD, IB and submission dossiers, aligned to ATMP requirements.
- Acting as a single point of contact ensuring close timeline management, regulatory compliance and transparent communication between all parties.
- Providing qualified local representatives in each region to support ongoing compliance and Health Authority interactions.
- As per the client’s request, Pre-IND meeting requests were submitted, along with clinical trials submissions for all regions, these were all approved with minimal RFIs and are currently ongoing.
Integrated regulatory and pharmacovigilance services streamlined authority interactions and safety reporting under a single, trusted provider.
Our Holistic Approach.
Arriello’s approach involved assembling a team of regulatory experts and experienced project managers, to utilize project management tools to oversee key milestones. This ensured adherence to timelines and regulatory requirements. By providing a clear communication path, efficiency was achieved, exceeding the client’s expectations and timelines.
Need support with complex ATMP submissions? Contact Arriello to discuss your regulatory strategy.
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