Arazy Group

Arazy Group Consultants Inc.

Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. They offer AI-powered solutions and expert guidance to accelerate market access in over 140 countries.

Arazy Group is a premier consulting firm with over 30 years of experience, dedicated to streamlining regulatory affairs and product registration for medical devices and IVDs. Their mission is to facilitate the global availability of innovative medical technologies. Leveraging cutting-edge AI-powered technology and deep regulatory expertise, Arazy Group provides solutions that expedite device registration in over 140 countries. Their platform offers customized submission files, automated compliance workflows, and real-time process management, significantly reducing time-to-market and associated risks. They offer comprehensive services including global authorized representative and license holder services, ensuring compliance and market access across diverse regions. Arazy Group's commitment to client success is demonstrated through personalized support and a focus on building long-term partnerships, making them a trusted advisor for companies ranging from startups to multinational corporations.

About

**Who they are**
Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. With over 30 years of experience, they leverage AI-powered solutions and expert guidance to accelerate market access.

**Expertise & scope**
* Specializes in regulatory affairs and product registration for medical devices and IVD products.
* Offers AI-powered regulatory technology products: LICENSALE® (Global MedTech Registration System) and REGISLATE® (Global MedTech Registration Management Software).
* Provides services in over 140 countries worldwide.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Expertise in navigating complex registration processes and ensuring market access throughout the product life cycle.

**Reputation / proof points**
* Over 30 years of experience in MedTech regulatory affairs.
* Trusted by 2500 companies.
* Facilitated over 4500 MedTech product registration activities worldwide.
* Global presence with offices in multiple countries.

Additional information

Arazy Group's approach combines technology with expert human guidance to streamline regulatory compliance. Their proprietary platforms, LICENSALE® and REGISLATE®, are designed to reduce the time and cost associated with gaining and maintaining market access globally. They emphasize separating market access activities from commercial operations by offering License holder and Authorized Representative services, allowing clients to control their markets independently of local distributors. This structure is particularly beneficial for companies seeking to expand into new territories efficiently.

Key Highlights

  • Specializes in regulatory affairs and product registration for medical devices and IVD products. Source
    “We are a leading consulting firm specializing in regulatory affairs and product registration for medical devices and IVD products.”
  • Offers AI-powered regulatory technology products: LICENSALE® and REGISLATE®. Source
    “The Arazy Group is the innovator behind the most effective and widely used MedTech regulatory technology products, LICENSALE® – Global MedTech Registration System and REGISLATE® – Global MedTech Registration Management Software (RMS).”
  • Provides services in over 140 countries worldwide. Source
    “We offer services available in 140+ countries worldwide, enabling companies a significant global advantage to gain market access in multiple countries without working with various consultants.”
  • Offers License holder and Authorized Representative services in more than 100 markets. Source
    “We also offer License holder and Authorized Representative services in more than 100 markets, enabling companies to separate their market access activities from commercial activities and control the markets independently from local distributors.”

Certifications & Trust Signals

  • Over 30 years of experience in MedTech regulatory affairs. Source
    “With over 30 years of experience, our team has helped thousands of MedTech companies successfully navigate the complex registration processes”
  • Trusted by 2500 companies. Source
    “30 Years Of Experience; 2500 Companies Trust Arazy Group”
  • Facilitated over 4500 MedTech product registration activities worldwide. Source
    “These cutting-edge solutions facilitated over 4500 MedTech product registration activities worldwide”

Buyer Snapshot

Best for
  • Companies seeking to accelerate medical device and IVD product registration globally.
  • Businesses needing to establish a local presence or representation in international markets.
  • Firms looking to leverage AI and technology for regulatory compliance.
How engagement typically works
  • Consultative approach to understand client needs.
  • Leverages proprietary technology platforms.
  • Provides expert guidance throughout the product lifecycle.
Typical deliverables
  • Regulatory strategy and planning.
  • Product registration and approval support.
  • Authorized Representative and License Holder services.
  • Access to AI-powered regulatory management software.
Good to know
  • Best when clients have clear product registration goals and require support in navigating complex international regulations.
HQ: Vancouver, Canada
Languages: English, German, French
Timezones: Europe/Zurich
Status: listed

Services & Capabilities

Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes

Jurisdictions: CH
Countries: CH
Industries: Medical devices, IVD
Portfolio: 26-100
Onboarding time: 1–5 days
Pricing model: Onboarding + annual retainer
Starting from: CHF 2,500
Included services: Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported: Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact: Yes
Can Be Named On Label: Yes

Additional ch_rep Details

Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Onboarding involves understanding client's specific requirements to provide tailored solutions for market access.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I, IIa, IIb and III for medical devices; Same as EU IVD for IVD devices.
Supports MDR
Implied through EU alignment and European Regulatory Representative Services
Supports IVDR
Implied through EU alignment and IVD product registration specialization
Labeling Support
Implied through offering services in Switzerland and mentioning EU classification alignment.
Swiss Local Contact
Not explicitly stated, but implied through offering services for the Swiss market.
Vigilance Contact Support
Implied through Authorized Representative and License Holder services.
Can Be Named On Label
Implied through Authorized Representative and License Holder services.
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