The World at Your Fingertips
From study start‑up to safety reporting, we help you navigate distinct, ever‑evolving regulatory landscapes with ease—wherever your trials are in the world.
- Dedicated people in 40+ locations
- Deep knowledge of local regulations, language, and culture
- Established relationships with regulators
- Global coverage through our regulatory service partner network
- Proven track record in managing multi‑region, multilingual submissions
Flexible Strategies for Regulatory Success
Every trial is unique, and so are our solutions. We provide tailored clinical trial regulatory services that help you avoid delays and expedite decision‑making.
- Personalized regulatory advice tailored to local landscapes
- Proactive alignment with trial objectives and timelines
- Versatile services to support our agile approach
- Interdisciplinary teams for total cross‑functional alignment
- Support across the entire lifecycle, wherever your trial is based
Efficient Pathways to Approval
Ensure regional compliance and streamline approval processes with expert preparation and management of regulatory documents, submission tracking, and multi‑region coordination.
- Real‑time identification of and reaction to regulatory change
- Risk reduction through culturally aware submissions
- Efficient start‑up through regulatory vendor partnerships
- Preparation and submission of clinical trial applications (CTAs)
- Full‑service CRO, supporting integrated workflows
Comprehensive Clinical Trial Regulatory Services
Access global resources combined with local expertise to support your pharmaceutical and medical device regulatory needs.
From preparing and submitting clinical trial applications to supporting investigators with Institutional Review Board or Ethics Committee documentation, we manage every detail.
Our commitment to regulatory compliance extends further—covering import/export permits, investigational product distribution, local labeling reviews, regulatory safety reporting, and pharmacovigilance oversight.
We provide bespoke, seamless, end‑to‑end support to ensure compliance and mitigate risks.
Case Study
Clinical Regulatory Services, Simplified
When a Phase III pancreatic cancer trial in China faced closure, we stepped in to keep it on track.
Navigating a complex regulatory landscape with tight timelines, we used our strong local relationships and regulatory knowledge to deliver:
- Complete management of regulatory procedures, including documentation and translations
- Expedited import/export and vendor contracting to ensure site readiness
- Activation of 60+ investigative sites
- Enrollment success through relationships with local key opinion leaders
Through expertise and dedication, we met all necessary timelines, salvaging the trial and paving the way for its global expansion.
See our impact in actionFrequently asked questions
What clinical trial regulatory services do you offer?
Our clinical regulatory services include CTA preparation, submission, ongoing support, and the preparation and submission of Institutional Review Board or Ethics Committee documentation.
We ensure seamless handling of import/export permits for investigational products and biological samples, and comprehensive investigational product management, including distribution to and from depots and trial sites.
Our services also extend to local labeling review, regulatory safety reporting, and regional safety and pharmacovigilance services.
Can you handle multi‑region regulatory submissions?
We’re your global partner with a proven track record in multi‑region regulatory success. With dedicated people in 40+ locations and clinical trials managed in 70+ geographies worldwide, we tailor strategies to your needs, considering the most current regional guidelines and local cultural dynamics in a global regulatory context. Our experienced, on‑the‑ground teams, embedded in local communities, are what make our solutions so impactful.
What steps do you take to ensure compliance with evolving regulations?
We monitor regulatory changes globally and adapt strategies to maintain compliance. Our dedicated team stays updated on evolving standards, liaises with local authorities, and proactively adjusts documentation, processes, and timelines so you can be confident that your trial aligns with the latest requirements in every region.
Do you provide documents in multiple languages?
Yes, we are a truly global provider of clinical trial regulatory services, providing documents in multiple languages. Our local experts ensure that all documents are accurate, culturally appropriate, and compliant with regional regulatory requirements.
Related Services
Project Management
Drive clinical research success with our experienced project management team, seamlessly coordinating functional areas and vendors across the trial lifecycle.
Study Design & Start‑Up
Partner with us to create custom, cost‑effective trial strategies that meet regulatory and sponsor requirements, regardless of project complexity.
Endpoint Adjudication
Generate reliable, unbiased data and advance your study to the next milestone with support from global experts and efficient workflows tailored to every program.
Medical Writing
Get accurate, compliant documentation for every trial. We combine local expertise with a global perspective to deliver success, from protocol development to regulatory submission.