When the Stakes Are High, Precision Matters
Asphalion is a highly regarded scientific and regulatory affairs consultancy supporting pharmaceutical and biotech companies through every stage of product development. Their expertise spans global regulatory strategy, dossier preparation, and end-to-end submission support. In the EU Marketing Authorization Application (MAA) process, Asphalion has a strong track record of helping sponsors achieve regulatory success.
As with many Clinical Research Organizations (CROs), Asphalion operates in a fast-paced, detail-intensive environment where timelines are non-negotiable and expectations are high. During a period of internal transition, they recognized the need for deeper linguistic support. Their team had historically managed communication between clients and external language vendors, but growing project complexity made this model harder to sustain. Regulatory deadlines were approaching, and their clients needed fast, accurate answers to specific language-related questions.
Rather than risk delays or confusion, Asphalion turned to long-time partner, BIG Language Solutions, for a more collaborative and integrated approach.
Stepping In with Expertise and Clarity
BIG Language Solutions brought more than just translation capacity to the table. With nearly 30 years of hands-on experience supporting EU regulatory submissions, we offered Asphalion a proven model for linguistic precision, process efficiency, and collaborative problem-solving.
We understood the unique demands of EMA submissions, including QRD compliance, MedDRA and EDQM term alignment, and the 5-day clock that begins once the final version of the English product information is approved. Our ISO 9001, ISO 17100, and ISO 27001 certifications reflect our commitment to quality, security, and industry-specific standards, and ensure every project meets regulatory and client expectations alike.
As part of our enhanced support for Asphalion, we joined client meetings as subject matter experts, representing their team and providing real-time guidance on linguistic requirements, terminology use, and submission formatting. To help streamline multi-language submissions, we developed structured project checklists that reduced back-and-forth communication and ensured all necessary information was aligned from the start. We also offered both white-labeled and co-branded service models, giving Asphalion the flexibility to choose the level of visibility that best suited each client relationship while maintaining consistency and quality throughout. Throughout every engagement, we ensured compliance at each stage; from reviewing the English product information and aligning with QRD templates to managing version control, final formatting, and secure delivery via Eudralink when needed.
All translation work was completed through BIG’s proven 10-step workflow, which includes translator and editor review, independent linguistic QA, formatting validation, and final sign-off by a dedicated project manager. For added assurance, key submissions were reviewed by in-country regulatory attorneys with subject-matter expertise in areas such as chemistry, biotechnology, and medical devices.
Smarter Workflows, Stronger Results
This approach allowed Asphalion to continue delivering world-class support to their clients while benefiting from a seamless, expert-led language process. Our work together has helped ensure that:
- No regulatory deadlines have been missed
- No submissions have been rejected or pushed back due to language-related issues
- Clients have increased confidence in both Asphalion and their regulatory readiness
Over years of collaboration, we’ve contributed to successful submissions across initial MAA filings, lifecycle updates, and urgent variations with a focus on accuracy, responsiveness, and alignment with EMA requirements.
This relationship illustrates what’s possible when two expert organizations come together with a shared commitment to quality. For Asphalion, BIG Language Solutions is more than a vendor. We’re a trusted extension of their team, helping their clients succeed where precision and timing matter most.
