Ensuring Compliance Without Interruption:
Agile Regulatory Solutions.
Client type:
Geography:
Lifecycle stage:
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Summary.
Our client, a global biopharma company with a diverse portfolio of biological and small molecule products, sought additional support to complement its Regulatory Affairs team for a defined period. We were engaged to provide local regulatory activities, including:
Coordinating local regulatory submissions initiated by the client’s global regulatory team.
Managing follow-up actions after approvals or requests for information (RFIs), in line with the client’s internal procedures.
Performing regulatory activities using the client’s procedures and systems.
Challenges.
Due to an unforseen overlapping of absences, our client faced a significant resource gap within their regional regulatory team, requiring an immediate and effective solution.
The ideal candidate required strong post-approval regulatory experience, flexibility, and familiarity with the client’s way of working, along with the ability to rapidly adapt to the client’s SOPs and systems.
To address this urgent need, the client turned to our experienced regulatory professionals for temporary support.
Solution.
We responded rapidly to the client’s urgent requirement by assigning a dedicated Regulatory Affairs Manager who could immediately integrate into the client’s team for the defined support period. Leveraging our extensive post-approval expertise in similar regulatory environments, onboarding process was kept to a minimum, enabling support to begin almost immediately.
To ensure full compliance with the client’s confidentiality and security requirements, the assigned professional was provided with a dedicated email address and laptop. This ensured appropriate access to the necessary systems and information, eliminating potential operational limitations, and enablled the regulatory manager to work fully within the client’s established procedures. As a result, our specialist functioned as a seamless extension of the client’s team from day one, without disruption.
Activities covered:
Coordinating local submissions for variations initiated by the client’s global regulatory team, including payments and country-specific documentation;
Coordinating post-approval and post-RFI follow-up activities, including triggering artwork (AW) requests and archiving;
Managing Veeva Vault/RIM activities, including document management, activity assessment, tracking variation-related information (e.g. approval dates and grace periods), and supporting requests for information;
Supporting requests received from National Competent Authorities unrelated to variations;
Supporting cross-country activities, covering additional markets beyond the initial scope to improve coordination of local activities for specific variations.
Provide our client with a clear strategy for the submission of PIPs, PIM, EAMs and EAPs in both the EU and UK.
As a result of our diligence and rapid adaptability, we ensured the client’s regulatory operations continued without interruption, despite a significant and unexpected resource gap.
Our Holistic Approach.
We focused on immediate reallocation of an experienced post-approval Regulatory Affairs professional, ensuring seamless integration into the client’s workflow. This rapid response addressed critical staffing gaps and maintained regulatory continuity.
By stepping in at a pivotal time, our tailored approach secured ongoing compliance, enabled the client to manage post-approval obligations effectively, and protected the product’s market position within the EU.
Looking for expert regulatory guidance? Contact Arriello for help navigating the complexities of medicinal product development and to find the right legal framework for your product.
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