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Introducing ALS Services
Premium Services
Contract Manufacturing & OEM Services
We proudly offer a full service medical device Contract Manufacturing & OEM Services with ISO 13485 certification and FDA registration. On average our specialists posses over 20 years of experience in assembly, testing, packaging and sterilization of medical devices. The company offers clean room and non-clean room assembly, testing and packaging services for class I and II medical devices, including sterile and non-sterile products.
Create Your Own Brand with Private Labeling
Private Labeling is one of the most effective ways to ensure that the products you carry reflect the unique identity of your company. Private Labeling allows you to create your own brand of products. By having your unique brand, customers are able to distinguish your products from competitors.
Regulation Compliance for Non US Entities
FDA Registration & Device Listing
It is often difficult to comprehend FDA standards and regulations. So, ALS Consulting team makes it convenient for companies to overcome the hurdles of complex paperwork required by FDA law. This FDA consulting support is particularly helpful to non-U.S. companies that may need to overcome language barriers, time barriers and cultural barriers with regard to U.S. government paperwork and requirements.
We provide the following expert Regulatory Services
U.S. FDA Medical Device Establishment Registration
U.S. FDA Medical Device Listings
U.S. Agent & Official Correspondent
We are able to get foreign manufacturer’s establishments registered with the FDA in a timely and cost effective manner. On occasion, we have fast tracked a registration application, due to pending export needs. We also can serve as the client’s Official Correspondent. In any case, we act as your conduit between your firm and the FDA.
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