United States of America
US FDA Representation, FDA Registration & FDA 510K Technical Service
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The United Kingdom
UK Representation, MHRA Registration & UKCA Technical Service
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European Union
EU Representation, EUDAMED Registration & CE Marketing Technical Service
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AEGIRBIO
A highly accurate test for detecting the COVID-19 virus using saliva. Simplified, qualitative, point-of-care test with results in 5-10 minutes. Avoids the complications of nasal swabs, blood draws, and delayed results.
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We’ll Ensure You Always Get The Best Result.

We are a reliable and competent medical device regulatory consulting firm that handles all of our customers fairly in all of our interactions. To minimize future misunderstandings, we attempt to raise customer knowledge of the regulatory role we will play with your team and the work we conduct in advance. We believe that personnel who work in our organization and service consumers should have proper knowledge and access to current regulatory information. They’re a big part of getting regulatory approval and certification early on. This belief should serve as the foundation of a successful regulatory consulting service that benefits customers and This, in turn, leads to consumer referrals and our company’s economic growth.

Our Main Service

ALS International Ltd. helps organizations to overcome regulatory hurdles by sharing, guiding, training and developing documents that of high quality, economically viable and assurance of clearance .

Reach Us

We will reply to your inquiry within the next 24 hours. If you have not heard from us, please do not hesitate to give us a call at the nearest location.

Book an appoitnment

+44 13 2241 3787

OUR GLOBAL PARTNERS

COVID-19 (SARS-COV-2) SALIVA TEST

The Aegirbio Viraspec COVID-19 Saliva Test is an easy-to-use lateral flow test that rapidly detects COVID-19 using saliva samples. When repetitive use is needed, or when testing on children, a nose swab or blood extraction is highly inconvenient.

The Viraspec COVID-19 Test uses a mix of saliva and dilution liquid that reacts to the COVID-19 antigen in under 10 minutes, giving an easily read result. Compared to RT-PCR, human clinical trials have shown the test to have a sensitivity of 90 % for SARS-CoV-2 infections with a specificity of 99.9 %.

Ideal for testing Covid-19 in:

  • Students before class
  • Athletes prior to games
  • Air and train passengers
  • Emergency triage
  • Transient populations

Each Kit Includes:

  • 25 Individually Pouched Test Cassettes
  • 25 Collection Tubes
  • 25 Extraction Buffer Tubes
  • 25 Saliva Collectors
  • 1 Workstation
  • 1 Package Insert

NowMed Sweden AB have created long-lasting and long-term relationships by representing high-quality items in many fields of business for over 30 years. NowMed Sweden can now provide and guarantee a variety of services based on these experiences and responsible communication.

Our company is energised by the prospect of aiding in the fight against the Corona virus and other known and undiscovered infectious diseases.

The Swedish diagnostic firm Aegirbio AB, which created the saliva-based fast test ViraspecTM, has chosen NowMed Sweden AB as its official Scandinavian sales and distribution partner.

For more information visit aegirbio.com

FDA CE ISO

Medical Devices

CE Marking according to new Medical Device Regulation (MDR 2017/745) and In-Vitro Diagnostic Regulation (IVDR 2017/746).

US FDA 510k clearance for medium risk and high-risk devices followed by device registration and listing.

I3CGlobal For EU Regulatory Compliance

New MDR 2017/745 for Medical Devices and IVDR 2017/746 for Invitro Diagnostics Devices regulations have raised tremendous compliance issues for already certified and new companies. I3CGlobal provide regulatory support for companies looking to find early compliance with less inhouse manpower.

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I3CGlobal For US FDA Regulatory Compliance

Complete regulatory consulting and support for Registration, 510k preparation and US Agent for all type of devices. The service offer comes with the assurance of success. Also the service offer comes with fixed fees tag.

Medical Device Regulation in India

A Regulatory strategy is inevitable to achieve Medical Device India regulatory compliance to obtain manufacturing or Import license. The new India regulatory requirements are much complex. Experts in the field can take solid regulatory strategy and execution plans. Team of regulatory affairs members from client organization in consultation with I3CGLOBAL team of experts will often have lead responsibility for developing the regulatory strategy.

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Why People Trust Us

An Amazing Team of Medical Device Consultants The leadership of ALS International Ltd. is capable of assisting its clients in removing compliance roadblocks.

Cloud Documentation

We are certified for ISO 2711 for data security. We work, we maintain and we deliver documents via the cloud with 24 x 7 uptime assurance.

Customer Response

To keep clients informed about the status of their projects, we employ a variety of communication methods which makes our customer response faster and accurate.

Precise Result

Advantages on having office all around world lets us get optimised and great result

Qualified Team

We believe in team work and having a great experienced and qualified members in our team makes it easy to achieve goals.

Get One Step Ahead with us

We make it seems effortless with our service for our client to overcome regulatory hurdles by sharing, guiding, training and developing documents. 

Address

Office 54, No:58, Peregrine Road, Hainault, Ilford, Essex, England. IG6 3SZ

Call Us

+44 75 8147 1399

Email Us

enquiry@alsinternationalltd.com