In the world of pharmaceutical development, Contract Research Organizations (CROs) carry a heavy responsibility. They coordinate complex timelines, manage communication between sponsors and regulators, and ensure that every piece of the submission puzzle fits together. When it comes to the EU Marketing Authorization Application (MAA) process, language is not just another task on the checklist. It is a core component of regulatory success.
At BIG Language Solutions, we work side by side with CROs to help them deliver regulatory-ready translations and multilingual documentation that meets the strictest compliance standards. But our value goes far beyond translation. We become an embedded partner that brings clarity, structure, and peace of mind in high-pressure submission environments.
Working with CROs Behind the Scenes and in the Spotlight
For many CROs, we operate quietly in the background. Our translations flow seamlessly into the larger submission process, and our name may never appear. In other cases, we step forward and work directly with the end client, answering questions and helping clarify regulatory expectations.
That flexibility is part of what makes our partnerships so effective. Our work with a global scientific and regulatory consultancy is a clear example. When their internal teams needed deeper linguistic expertise during a period of organizational change, we expanded our role to provide direct support across multiple fronts.
We participated in client meetings as subject matter experts, offering real-time guidance on terminology, linguistic formatting, and QRD template alignment. We designed structured project checklists to simplify the information-gathering process and reduce friction between stakeholders. And we adapted to each relationship by offering both white-labeled and co-branded service models, ensuring every engagement felt seamless, consistent, and well supported.
A Process Built for Regulatory Precision
Our process is grounded in decades of regulatory experience. Every submission goes through a carefully structured workflow that includes professional translation, bilingual editing, independent quality review, version control, and QRD layout-compliant formatting. For mission-critical documents, we also engage in-country regulatory attorneys with relevant subject-matter expertise to provide final checks before delivery.
We support the entire EU MAA lifecycle from initial English product information review to multilingual translations for submission, variations, and renewals. Our team ensures alignment with QRD templates, MedDRA and EDQM terminology, and EMA formatting requirements. If needed, we manage delivery through Eudralink and provide both clean and tracked files to simplify client-side review.
Proven Results in High-Stakes Submissions
We understand what is at stake. In our long-standing work with CROs we have helped ensure that no regulatory deadlines are missed and no documents are rejected or delayed due to linguistic issues. Our record is clear. Our clients are confident. And our quality-first approach continues to deliver measurable value across every submission we touch.
A Smarter Approach to Language Support
The EU MAA process leaves little room for error. CROs who partner with BIG Language Solutions gain more than a vendor, they gain a strategic ally who understands both the regulatory landscape and the operational realities of life sciences.
Whether you need structured workflows, subject matter expertise, or simply a reliable partner to handle the language piece, we are here to help you move forward with confidence.
Let’s talk about how we can support your next submission.
