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 with over 30 years of experience, specializing in the registration of medical devices and IVD products. They leverage AI-powered solutions and expert guidance to facilitate market access.

**Expertise & scope**
* Specializes in medical device and IVD product registration.
* Offers AI-powered regulatory technology solutions, including LICENSALE® and REGISLATE®.
* Provides global market access support in over 140 countries.
* Offers License Holder and Authorized Representative services in over 100 markets.
* Expertise in navigating complex registration processes for MedTech companies.
* Provides tailored compliance solutions to meet unique client needs.

**Reputation / proof points**
* Over 30 years of regulatory experience.
* Supported thousands of MedTech companies.
* Facilitated over 4500 MedTech product registration activities worldwide using their technology.
* 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 automate and manage registration processes, aiming to reduce both the time and cost associated with gaining and maintaining market access. For companies seeking to establish a presence in Switzerland, Arazy Group can assist with understanding the regulatory landscape governed by Swissmedic, where medical devices are classified similarly to the EU model. License validity in Switzerland is typically tied to the CE Mark, often extending for five years.

Key Highlights

  • 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”
  • Offers AI-powered regulatory technology solutions: 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).”
  • Supports market access 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”
  • Provides Authorized Representative and License Holder services in over 100 markets. Source
    “We also offer License holder and Authorized Representative services in more than 100 markets”

Certifications & Trust Signals

  • Trusted by 2500 companies. Source
    “2500 Companies Trust Arazy Group”
  • Facilitated over 5000 applications. Source
    “5000 Applications”

Buyer Snapshot

Best for
  • Medical device and IVD manufacturers seeking global market access.
  • Companies needing specialized regulatory affairs consulting.
  • Businesses looking to leverage AI in their compliance processes.
How engagement typically works
  • Consultative approach to tailor solutions.
  • Technology-driven process management.
  • Partnership for long-term market access.
Typical deliverables
  • Regulatory strategy development.
  • Product registration and approval support.
  • Authorized Representative and License Holder services.
  • AI-powered regulatory management software.
Good to know
  • Best when clients have a clear understanding of their product classification and target markets.
HQ: Vancouver, Canada
Languages: English, German, French
Timezones: Europe/Zurich
Claim status: Listed

Services & Capabilities

Find 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
Swiss Local Contact: Yes
Can Be Named On Label: Yes
Labeling Support: Yes
Vigilance Contact Support: Yes
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