Skip to main content

Search

 

  •  
  •   +1 908 483 7958
  •   sales@freyrsolutions.com
Home
 
 
 

Main navigation

  • Home
  • Regionwide Expertise
    • Americas
    • U.S.
    • Canada
    • LATAM
    • Brazil
    • Mexico
    • Middle East
    • UAE
    • Saudi Arabia
    • Europe
    • European Union
    • United Kingdom
    • Netherlands
    • Italy
    • Germany
    • France
    • Switzerland
    • Asia Pacific
    • China
    • India
    • Indonesia
    • Japan
    • Malaysia
    • South Korea
    • Australia
    • Taiwan
    • Sri Lanka
    • Turkey
    • Vietnam
    • Thailand
    • Africa
    • Nigeria
  • Services
    • In-country Representation 
    • European Authorized Representative (EAR)
    • US Agent Service
    • Local Authorized Representative Support – ROW
    • Authorized Representative
    • UKRP
    • Swiss CH-REP
    • Device Registration in USA
    • 513(g) Submission
    • 510(k) Submission
    • De-Novo Registration of Medical Devices
    • Q-Submission Meeting
    • Premarket Approval
    • RFD and Pre-RFD
    • Device Registration in EU
    • In Vitro Diagnostic Regulation (IVDR)
    • European Medical Device Classification
    • EU MDR
    • Medical Device Registration - RoW Market
    • Medical device Registration – LATAM
    • Device Registrations-SaMD
    • Medical Writing
    • Clinical Evaluation Report (CER)
    • Post Marketing Surveillance Support (PMSS)
    • Performance Evaluation Report (PER)
    • Device Documentation
    • ISO 14971 Risk Management Consulting
    • Design History File
    • Device Technical File Publishing
    • Medical Device Labeling
    • Medical Devices Artwork Services
    • QMS
    • ISO 13485:2016 Compliance
    • Regulatory Compliance, Gap Analysis & Remediation
    • 21 CFR 820 Compliance
    • Strategy
    • Regulatory Intelligence
    • Regulatory Strategy
    • Regulatory Submission and Registration
    • Staff Augmentation
    • Translation Support
    • Technical Writing
  • Resources
    • Blogs
    • Brochures
    • Case Studies
    • Infographics
    • Webinars
    • What is ...?
    • White Papers
    • Global Delivery Model
  • About Us
    • Testimonials
  • Contact Us

Case Studies

  • Multiple
    Multi-country Regulatory Intelligence Services for Health Care Mobile Application
    Read More
  • North America
    Successful NDA Medical Device Submissions Within 16 Days
    Read More
  • North Africa & Middle East
    End-to-end Gap Analysis and Regulatory Consultation for the SFDA Marketing Authorization Submissions
    Read More
  • US FDA
    First-Time-Right Solution For 99.7% Tasks for UDI Submission
    Read More
  • US FDA
    End-to-End Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions
    Read More
  • COFEPRIS
    Device Classification, Regulatory Approach Identification and Registration Services in Mexico
    Read More
  • CDSCO
    Medical Device Classification Support in India (As Per CDSCO)
    Read More
  • CDSCO
    Regulatory Intelligence on PPO Policies in India
    Read More
  • COFEPRIS
    Successful Regulatory Support for A Technical Change with COFEPRIS
    Read More

Pagination

  • Current page 1
  • Page 2
  • Page 3
  • Next page ››
  • Last page Last »

Subscribe To

Our Newsletter

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

 

What our Clients say

Director, Regulatory Affairs,

US based leading precision medicine company

We have had a good impression of Freyr and feel more than comfortable telling our partners that we are engaging with Freyr for our Regulatory needs. The project went very smoothly, and at a reasonable pace. The team was knowledgeable, friendly and accommodating. Rapid response appreciated. Keep up the good work.

Director, Regulatory Affairs,

US based leading precision medicine company

Speed of service, responsiveness, attention to our needs, quality of product, and price are all very important and I felt they were very good in our work with Freyr. Service was delivered appropriately and in a timely fashion. Thankful to Freyr’s responsive team because of which we could comprehend our unusual needs. I thought the support was very good and met with expectations. In addition, found the price reasonable given the workload.

Regulatory Affairs Officer

A Global Industry Leader in Medical Device Design and Manufacturing

You have exceeded our expectations as a team and individuals! Special thanks for all the prepared technical documentation!! What an effort team! Again, many thanks for all the work and efforts put into this, moving forward positively. Thank you for your consistency, perseverance, and amazing teamwork at Freyr. we would like to express our gratitude to the Freyr team for all the great work and expertise that they have brought to the project to make it a success!

Associate, Regulatory Affairs Team II,

Clinical & Regulatory Affairs Center,
A Korean Chemical Company

Thank you so much Freyr team for your support on the way in registering 3 of our medical devices in Philippines.
I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.

Manager, Regulatory Affairs

A Spanish Medical Devices Manufacturer

Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!

Director, Regulatory Affairs

US based top Sterilization company

The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?

   

Let’s connect

We’re here to help and answer any question you might have.
We look forward to hearing from you.
CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

GET IN TOUCH

Call us

USA

+1 908 483 7958 / +1 908 409 5626

UK

+44 2037 012379

GERMANY

+49 618 170 79007

INDIA

+91 40 4848 0999

More Locations

Email us

sales@freyrsolutions.com

Terms of Use | Privacy Policy

© Copyright 2022 Freyr. All Rights Reserved.

 
CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Quick Inquiry

Quick Inquiry
x