Global Regulatory Partners
Global Regulatory Partners, Inc.
Global Regulatory Partners (GRP) offers end-to-end regulatory affairs, clinical, quality, and pharmacovigilance services for medical devices, pharmaceuticals, cosmetics, and nutraceuticals. FDA U.S. Agent, 510(k) submission, PMA, regulatory strategy, and Q-Sub meeting support.
Global Regulatory Partners (GRP) offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements. With local offices in USA, Japan, China, Brazil, Mexico, and Korea, GRP provides FDA U.S. Agent designation, FDA communications, establishment registration, product listing, and inspection support. Beyond U.S. Agent services, GRP offers full 510(k) submission support (Traditional, Abbreviated, Special, De Novo), PMA for Class III devices, regulatory intelligence and strategy, medical writing, product registration, Q-Sub/Pre-sub meeting preparation with FDA, clinical trials management, quality audits (QSR, ISO 13485, mock FDA inspections, gap analysis), and pharmacovigilance. GRP has prepared, submitted, and cleared many 510(k)s for Class II medical devices and IVDs, and organized over 100 consultation meetings with FDA.
About
Global Regulatory Partners (GRP) offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements. With local offices in USA, Japan, China, Brazil, Mexico, and Korea, GRP provides FDA U.S. Agent designation, FDA communications, establishment registration, product listing, and inspection support. Beyond U.S. Agent services, GRP offers full 510(k) submission support (Traditional, Abbreviated, Special, De Novo), PMA for Class III devices, regulatory intelligence and strategy, medical writing, product registration, Q-Sub/Pre-sub meeting preparation with FDA, clinical trials management, quality audits (QSR, ISO 13485, mock FDA inspections, gap analysis), and pharmacovigilance. GRP has prepared, submitted, and cleared many 510(k)s for Class II medical devices and IVDs, and organized over 100 consultation meetings with FDA.
Key Highlights
- FDA U.S. Agent with local offices in USA, Japan, China, Brazil, Mexico, Korea
- Full 510(k) submission support: Traditional, Abbreviated, Special, De Novo; GRP has prepared and cleared many 510(k)s
- PMA support for Class III devices; regulatory intelligence, strategy, and medical writing
- Q-Sub / Pre-sub meeting preparation and attendance; over 100 FDA consultation meetings organized
- Clinical trials support, quality audits (QSR, ISO 13485, mock FDA inspections), pharmacovigilance
- Serves medical devices, pharmaceuticals, cosmetics, nutraceuticals, and food supplements
Certifications & Trust Signals
- Local offices in USA, Japan, China, Brazil, Mexico, Korea for global reach
- Prepared, submitted, and cleared many 510(k)s for Class II medical devices and IVDs
- Organized over 100 consultation meetings with FDA; regulatory affairs and clinical expertise
Pricing
Model:
Retainer
Public range:
Pricing varies by scope; request quote for U.S. Agent and 510(k) services
Notes:
U.S. Agent retainer typically includes registration, listing, communications; 510(k) and PMA priced per project
HQ:
Boston, USA
Languages:
English
Timezones:
America/New_York
Claim status:
Claimed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, Pharmaceuticals, Cosmetics, Nutraceuticals, Food supplements
Portfolio:
6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 1,800
Included services:
FDA U.S. Agent designation and communications, Establishment registration and product listing (FURLS), Annual renewal reminders and reporting, FDA inspection assistance, Adverse effects reporting (MDR), 510(k) submission preparation and clearance (Traditional, Abbreviated, Special, De Novo), PMA support for Class III devices, Regulatory intelligence and strategy, Q-Sub / Pre-sub meeting preparation with FDA, Medical writing for FDA submissions, Product registration support, Clinical trials support, Quality audits (QSR, ISO 13485, mock FDA inspections, gap analysis)
Registration Support:
Yes
Time Zone Coverage:
America/New_York
Product Type:
devices, drugs, cosmetics, food
Service Types:
US Agent Services, FDA Registration/Listing Support
Annual Renewal Support:
Yes
Inspection Support:
Yes
Annual Renewal Reminder:
Yes
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical devices
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
1–14 days
Pricing model:
Per project
Included services:
510(k) strategy and authoring, 510(k) eSTAR preparation, Traditional, Abbreviated, Special 510(k) support, De Novo strategy and authoring, PMA strategy and support, Pre-Sub / Q-Sub preparation, FDA meeting support, Labeling review for submissions, Regulatory pathway assessment, Device classification support, Predicate research and substantial equivalence strategy
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare Global Regulatory Partners and other vetted providers — instant pricing, no RFQ needed.
