Most Commonly Questions Asked
Is Qualimax LLC audited by the FDA?
Yes, Qualimax LLC is registered and audited by the FDA on a periodic basis.
Is Qualimax LLC registered with FDA?
Yes, Qualimax LLC is registered with the FDA and our registration number is 3004599007.
Does Qualimax LLC follow FDA regulations?
Yes, Qualimax LLC follows Current Good Manufacturing Practices (cGMP) per CFR section Title 21, part 820, Title 21, part 811, Title 21 part 11.
How do I get a price quotation?
Please use our contact form or call and ask for a salesperson at (201) 313.3353. Please indicate the type of product that needs testing and the testing required. If we are able to perform the testing, a quotation detailing the price, turnaround time and sample requirements will be sent to your attention.
How do I get a price list?
Qualimax LLC does not offer a published price list, however, a price quotation tailored to specific testing needs will be provided.
How do I submit samples to Qualimax LLC?
Samples should be shipped to Qualimax LLC to the attention of the “Sample Receiving” department.
Qualimax LLC
Attn: Receiving Department
65 Railroad Avenue
Suite 205
Ridgefield, NJ 07657
All samples must have a signed sample submission form indicating the tests requested. All microbiological, chemistry and other samples are to be shipped to the above address. Receiving hours are 7:30 am to 4:00 pm Monday through Friday (excluding Holidays).
How do I obtain a copy of the test method?
Test methods, which are not Qualimax LLC in-house developed and validated, can be provided to the client. All test methods can be reviewed on site during an audit of Qualimax LLC. If an internal method is requested by a Government agency, Qualimax LLC will provide the method directly to the agency. Minimal cost will be charged to the client for preparing and forwarding these documents.
Why do test methods need to be validated or verified?
Current Good Manufacturing Practice (cGMP) regulations [21 CFR 211.194 (a)] require that test methods, which are used for assessing compliance of OTC products with established specifications, must meet proper standards for accuracy and reliability. In addition, microbiological test methods may require validation per pharmacopoeia (USP, EP, etc.) requirements. Qualimax LLC will validate all its methods for each product at no charge to clients. If client should need to obtain the validation data, there will be charge to the client for the cost of validation.
How are the reports issued?
All reports will be sent via email to the customer.
What type of a report is issued after the testing is completed?
The final signed report on company letter head will detail the client information, sample description and identification, tests performed and results of such tests. It will also indicate the internal sample identification code.
