Global Regulatory Partners

Global Regulatory Partners, Inc.
Verified

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

**Who they are**
Global Regulatory Partners (GRP) is a firm providing comprehensive regulatory affairs and compliance services across multiple product categories. They leverage a global network of local experts to navigate diverse market requirements.

**Expertise & scope**
* End-to-end regulatory affairs and compliance for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements.
* Services include regulatory intelligence, strategy development, and pathway definition for product registration.
* Act as authorized local agents in various countries for medical devices and in-vitro diagnostics.
* Support for regulatory bodies including the US FDA, Health Canada, COFEPRIS (Mexico), and EMA (Europe).

**Reputation / proof points**
* Global presence with local expertise in various countries.

Additional information

Global Regulatory Partners emphasizes the importance of regulatory intelligence (RI) as a critical tool for professionals. RI enables the development of effective regulatory strategies for product development, registration, and commercialization. They offer tailored RI, incorporating the latest regulatory information and strategic recommendations to meet specific client needs. Their services span the entire product lifecycle, from concept through development to registration.

Key Highlights

  • Offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements. Source
    “Global Regulatory Partners (GRP) offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements.”
  • Acts as authorized local agents in various countries for medical devices and in-vitro diagnostics. Source
    “Global regulatory Partners, Inc. (GRP) has local offices and strategic partners worldwide that are licensed by local authorities to act as your local agent in many countries for your medical devices and in-vitro diagnostics.”
  • Provides regulatory intelligence, strategy, and pathway development for product registration. Source
    “GRP has a global presence with teams of local experts who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in different markets.”

Certifications & Trust Signals

  • Recognizes the US FDA as a key regulatory body they support. Source
    “United States’ FDA”

Buyer Snapshot

Best for
  • Companies seeking local agent representation in the US and other global markets.
  • Manufacturers requiring regulatory strategy and intelligence for product registration.
  • Businesses navigating complex regulatory environments for pharmaceuticals and medical devices.
How engagement typically works
  • Partnership for end-to-end regulatory support.
  • Leveraging local expertise for market-specific compliance.
Typical deliverables
  • Regulatory intelligence reports.
  • Product registration strategies.
  • Local agent services.
  • Compliance consulting.
Good to know
  • Best when requiring global reach with local regulatory knowledge.
HQ: Boston, USA
Public email: voviedo@globalregulatorypartners.com
Phone: +1 ) 781 - 672 -4200
Languages: English
Timezones: America/New_York
Access: Verified
Claim status: Claimed

Services & Capabilities

Best 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

Additional us_agent_fda Details

Product Types
Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, Food Supplements, In-vitro Diagnostics
Registration Support
Yes
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