Global Regulatory Affairs Advisors
Let the GRA Advisors help you with your regulatory and clinical trial needs in major international markets efficiently and effectively.
Just Ask!
“A single conversation across the table with a wise man is better than ten years mere study of books.”
-Henry Wadsworth Longfellow
Why Us
We follow the 'Glocal' approach—Think Global, Act Local.
Our advisors bring over 25 years of industry experience and offer tailored regulatory strategies.
We help small, mid-size, or large biopharmaceutical companies remove regulatory barriers using our in-depth knowledge of local, regional, and global regulations.
We thrive because of our market knowledge, local connections, our reputation, and outstanding team of advisors. Just Ask!
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About GRA Advisors
Whether you’re a start-up planning to enter clinical trials, a clinical-stage company expanding your trial footprint, or an established firm with approved products seeking global expansion, we can assist. Struggling with regulatory approvals or need a second opinion? We’ve got you covered!
Our seasoned advisors bring over 25 years of industry experience, having worked with multinational companies across various therapeutic areas and modalities.
GRA Advisors operates globally, with our headquarters in the US and a network of country-based advisors in China, India, Japan, Korea, and Taiwan. Our regional presence extends through ASEAN, AfME, and LATAM, and includes experts from the WHO, representing regulatory expertise in over 100 countries.
Free Consultation
Our Services
Core Services
We provide end-to-end regulatory services:
- Develop innovative regulatory strategies for efficient drug registration
- Health authority consultation
- Advisory committee meetings with KOLs/SME
- We can be the in-country license holder—clinical trials or MAH
- Clinical study design for MRCT, regional or local registration studies
- Life-cycle management
- Plant/site registration
- Advance regulatory policy and advocacy
- Regulatory intelligence
- Pharmacovigilance and drug safety
Expanded Services
Through our extensive in-country and regional network we can facilitate introductions with well-reputed local CROs, vendors and experts
- Clinical Trial Operations (planning, execution, and management).
- Regulatory Operations (e.g., medical writing, submissions, publishing, translation)
- Pricing & Reimbursement
- Legal Advice
- Partnerships and Joint Ventures
- Manufacturing/CDMO
- Third-party Logistics
- Patient Access
- Preclinical Research
- Product Launch Strategies
- Help establish new country offices
- RWE and Commercial insights
- Facilitate local partnerships for commercialization/licensing
- Create a regional presence through the innovative “hub & spoke” FSP model.
