WELO LIFE SCIENCES + AMGEN
Already approved. Already here. Already delivering.
Welo Life Sciences has supported Amgen’s regulatory, clinical, and pharmacovigilance teams since 2012. This page is a resource for the full Amgen team to see where we work together today and where we can move faster.
Who We Support at Amgen Today
Welo Life Sciences has been an approved translation vendor for Amgen since 2012. Over that relationship we have delivered regulatory and clinical translation, pharmacovigilance documentation, and linguistic validation work, across the US, Brazil, and Austria, covering the workstreams that sit on Amgen’s critical path.
The pipeline running right now is some of the most time-sensitive in the industry. TAVNEOS safety updates, the IMDYLLTRA EU launch, and the UPLIZNA international rollout each have their own country-specific clocks. We are built for exactly that kind of pressure, and we are already here.
OUR APPROACH
Where We Can Move Faster Together
Not capabilities. Not features. Commitments: measurable, accountable, and specific to the complexity of global clinical operations.
Safety and
Labeling
Rapid-response, multi-market delivery with full audit trails and first-pass acceptance tracked and reported.
EU Launches and Global Rollouts
In-region expertise, centralized terminology governance, and MLR-ready content, so every market launches on time.
Dedicated Partnership Model
A dedicated Amgen team, outcome-based SLAs, and a monthly quality review built into the standard workflow.
300+
Languages with clinical-grade coverage
99.2%
On-time delivery rate across clinical programs
25+
Years supporting regulated life sciences content
Top 10
Global pharma companies served by our clinical teams
SAFETY AND LABELING
Rapid-Response Safety and Labeling, Built for Multi-Market Speed
We turn around multi-country safety and label updates quickly, with clear ownership and audit-ready files, speed and quality delivered together, not traded off.
Amgen is executing urgent TAVNEOS safety updates, the IMDYLLTRA EU launch, and the UPLIZNA international rollout, all running in parallel, each on tight country-specific timelines. Translation sits on the critical path for all three.
Regulatory scrutiny on safety content means consistency between markets is not optional. A wording difference is exactly what draws health authority questions. The standard here is not just fast, it is fast, consistent, and demonstrably compliant.
What we bring to your safety and labeling workstreams:
- 6-hour turnaround on urgent safety translations; reliable 12–24 hours on wider PV documentation
- PV-trained linguists and standardized Amgen terminology, with a documented QC step on every file
- Full audit trails and health-authority-ready outputs across 50+ markets
- First-pass acceptance tracking reported on a schedule so quality is visible to your stakeholders, not just asserted
- Follow-the-sun coverage so a safety update reaches every market simultaneously regardless of time zone
LAUNCHES AND GLOBAL ROLLOUTS
De-Risking EU Launches with In-Region Excellence
Welo Life Sciences de-risks first-wave launches through centralized terminology governance, MLR-ready content, multilingual artwork and DTP, and in-country review, so submissions go in right the first time.
IMDYLLTRA received EU marketing authorization on June 1. The immediate work is translated product information across Annex I to III — SmPC, labeling, and package leaflet, plus national-phase linguistic review across member-state languages. It is running alongside the current TAVNEOS safety changes, both on tight country-specific clocks.
First-wave launches that require rework cost more than time. They cost market position. Centralized terminology governance from day one is what keeps review cycles short and rework out of the timeline.
What we bring to your EU launches and global rollouts:
- Submission-ready EU labeling and dossiers (QRD, SPL, Health Canada, MDR) with structure and formatting preserved for direct filing
- CTD/eCTD coverage end to end plus national-phase adaptations, variations, and renewals
- In-region linguists and local reviewers so wording is adapted for each market, not just translated
- MLR-ready content with documented terminology governance that cuts review cycles and reduces rework
- Market access support for HTA dossiers including NICE, G-BA, HAS, and AIFA
DEDICATED PARTNERSHIP MODEL
A Dedicated Amgen Team, Measured on Outcomes
A dedicated, cross-functional Welo team for Amgen — measured on clear outcomes: speed, first-pass acceptance, and inspection readiness — backed by follow-the-sun capacity and a monthly quality review built into the standard workflow.
Global trials, submissions, and safety reporting run on fixed clocks. Translation sits on the critical path for all of them. The dedicated Amgen team at Welo is not assembled when work arrives. It is a named group with defined roles, response targets, and a monthly quality review that tracks and reports first-pass acceptance across every workstream.
What the dedicated Amgen partnership looks like:
- – Dedicated team with defined roles, on-call hours, and a simple escalation path
- SLAs tied to your timelines, not generic benchmarks — safety, submission, and launch windows each have their own targets
- Monthly quality review with first-pass acceptance rates reported on a schedule
- Elastic surge capacity planned in advance for safety updates, submission cycles, and launch peaks
- Outcome-based governance: right-first-time rates and inspection-ready audit trails built into the standard workflow
WHY WELO LIFE SCIENCES
What Sets Us Apart for This Account
Life sciences expertise, rare disease fluency, at scale.
Welo Life Sciences works exclusively in life sciences. Oncology, inflammation, rare disease, and cardiovascular are our highest-volume therapeutic categories, which maps directly to Amgen’s portfolio following the Horizon Therapeutics acquisition. GxP-aware, audit-ready workflows and rigorous terminology governance mean MLR cycles stay short and rework stays low.
In-region delivery aligned to Amgen’s global footprint.
Amgen operates across North America, Europe, APAC, and LATAM with sites in the US, Puerto Rico, Ireland, the Netherlands, and Singapore. Welo matches that footprint with in-region medical linguists, reviewers, and rapid-response coverage, time zone continuity for safety updates, labeling, and launch materials across every market.
Quality you can show your stakeholders.
First-pass acceptance rates tracked and reported monthly. Inspection-ready audit trails built into the standard workflow. A dedicated team that knows Amgen’s documents, not a rotating pool that needs re-briefing on every project.
YOUR WELO LIFE SCIENCES CONTACT
GET IN TOUCH
Ready to move faster, together?
Whether you are a current Amgen contact or a colleague on a team we have not yet worked with, we are easy to find and ready to help,