Global Regulatory Partners

Global Regulatory Partners, Inc.

Global Regulatory Partners (GRP) offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements. They provide global reach with local expertise, acting as authorized local agents in various countries.

Global Regulatory Partners, Inc. (GRP) provides comprehensive regulatory affairs and compliance services across the entire product lifecycle, serving industries such as Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, and Food Supplements. With a "Global Reach, Local Presence and Expertise" approach, GRP has local offices in the USA, Asia, Latin America, and Europe, enabling them to offer localized support. GRP specializes in assisting companies with navigating complex regulatory environments. They offer services including Regulatory Intelligence, strategy development, and acting as an Authorized Local Agent in key markets like the United States (FDA), Canada (Health Canada), Mexico (COFEPRIS), and Europe (EMA). Their expertise is particularly valuable for medical device companies seeking to register and commercialize products in new markets. The company emphasizes developing tailored regulatory strategies to meet specific business objectives, minimize risk, and ensure efficient product development, registration, and commercialization. GRP's team provides insights into necessary documentation, timelines, costs, and action plans to help clients achieve their milestones.

About

**Who they are**
Global Regulatory Partners (GRP) is a firm that offers comprehensive regulatory affairs and compliance services across various industries, including pharmaceuticals, medical devices, cosmetics, nutraceuticals, and food supplements. They emphasize their global reach combined with local expertise.

**Expertise & scope**
* Provides end-to-end regulatory affairs and compliance services.
* Acts as authorized local agents in numerous countries, leveraging local offices and strategic partners licensed by local authorities.
* Specializes in developing regulatory intelligence, strategy, and pathways for product registration in different markets.
* Offers services for medical devices and in-vitro diagnostics.
* Supports regulatory affairs from product concept through development to registration.
* Covers regulatory bodies including the United States' FDA, Canada's Health Canada, Mexico's COFEPRIS, and Europe's EMA.

**Reputation / proof points**
* Global presence with teams of local experts.

Additional information

Global Regulatory Partners assists clients in navigating complex and evolving regulatory environments. Their approach involves developing tailored regulatory intelligence, which includes the latest information and strategic recommendations to ensure efficient and cost-effective product development, registration, and commercialization. They are equipped to act as local agents for medical devices and in-vitro diagnostics in various international markets, providing a crucial link for companies seeking to enter or expand their presence in these regions.

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, leveraging local offices and strategic partners. 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.”
  • Develops regulatory intelligence, strategy, and pathways for product registration in different markets. Source
    “Global Regulatory Partners Inc. (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 regulatory bodies such as the United States' FDA. Source
    “United States’ FDA”
  • Supports regulatory affairs for medical devices and in-vitro diagnostics. Source
    “act as your local agent in many countries for your medical devices and in-vitro diagnostics.”

Buyer Snapshot

Best for
  • Companies seeking regulatory affairs and compliance services.
  • Businesses requiring local agent representation in international markets.
  • Medical device and IVD manufacturers navigating global registrations.
How engagement typically works
  • Partnership for regulatory strategy development.
  • Acting as a licensed local agent.
  • Providing regulatory intelligence and guidance.
Typical deliverables
  • Regulatory strategy and pathway development.
  • Local agent services.
  • Regulatory intelligence reports.
  • Product registration support.
Good to know
  • Best when requiring specialized regulatory expertise for global market entry.
HQ: Boston, USA
Languages: English
Timezones: America/New_York
Status: listed

Services & Capabilities

Best FDA US Agent Services | Compare & Get Quotes

Jurisdictions: US
Countries: US
Industries: Medical devices, Drugs, Cosmetics
Portfolio: 6-25, 26-100, 100+
Onboarding time: 2–7 days
Pricing model: Retainer
Starting from: USD 1,800
Included services: FDA communications handling, Establishment registration support, Product listing assistance, Annual renewal reminders
Registration Support: Yes
Product Type: devices
Service Types: US Agent Services, FDA Registration/Listing Support

Additional us_agent_fda Details

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