Frequently Asked Questions

How do I start testing with BioScreen?
How do I get a price list?
How do I get a price quotation?
How do I pay for the testing?
How can a company establish credit with BioScreen?
How do I submit samples to BioScreen?
How can the samples be returned to the client?
Does BioScreen follow FDA regulations?
Since you are a laboratory why do you not follow cGLP?
Is BioScreen registered with FDA?
Can BioScreen test controlled substances?
Can BioScreen test for asbestos?
Can BioScreen test for lead on paint?
Why do test methods need to be validated?
I need to obtain a copy of an old report.
What type of a report is issued after the testing is completed?
Can I obtain a copy of the test method?
Can I obtain copies of the raw data (notebook pages or chromatograms)?
How are reports issued?
Who do I speak to discuss the results on the report?
Is BioScreen audited by the FDA?
How do I schedule an Audit of BioScreen?
Does BioScreen complete vendor surveys or paper audits?
Is BioScreen ISO Certified?
Do you have more than one location?

How do I start testing with BioScreen?
You can contact BioScreen via email (info@bioscreen.com), telephone (310) 214-0043 or fax (310) 370-3672.  Please provide your address, contact information, and testing requirements.  A price quotation, standard terms, payment terms and a sample submission form will be sent for your approval.  Please sign the quotation and fax it back to BioScreen.  Ship the samples to BioScreen along with a completed and signed sample submission form and payment.

How do I get a price list?
BioScreen does not offer a published price list.  However, a price quotation tailored to your specific testing needs will be provided.

How do I get a price quotation?
Please write, email (info@bioscreen.com) or call and ask for a salesperson at (310) 214-0043.  Please indicate the type of product that needs testing and the testing required.  We may ask you to complete a form for stability (download Word document) and clinical testing requests (download Word document).  If we are able to perform the testing, a quotation detailing the price, turn around time and sample requirements will be sent to your attention.

How do I pay for the testing?
BioScreen requires prepayment via check, money order, credit card (Master Card,Visa or American Express) or wire transfer until credit is established.

How can a company establish credit with BioScreen?
A blank credit application will be sent for all new clients.  Please complete the credit application and return it to BioScreen.  It will take 2 to 3 weeks to process the completed credit application.  Please note that we require prepayment for all new accounts for the first order even if the credit application has been received. 

How do I submit samples to BioScreen?
Samples should be shipped to BioScreen Testing Services to the attention of the "Sample Receiving" department.  All samples must have a signed sample submission form indicating the tests requested

BioScreen Testing Services,
Sample Receiving Department
3892 Del Amo Blvd, Suite 703
Torrance, CA 90503

All microbiological, chemistry and clinical samples are to be shipped to the above address.

How can the samples be returned to the client?
Please indicate on the samples submission form that unused samples are to be returned to the client.  Indicate how the samples should be returned and list the account number of the courier you wish us to use (FedEx or Airborne).

Does BioScreen follow FDA regulations?
Yes, BioScreen follows current Good manufacturing Practices per CFR section Title 21, part 820, Title 21, part 811, Title 21 part 11. 

Since you are a laboratory why do you not follow cGLP?
BioScreen performs testing per cGLP requirements at the request of the client.  cGLP are covered in CFR section Title 21 part 28.  Please request a quotation for the additional charges that will be incurred for cGLP testing.   In addition, the request must be made prior to the start of the study.

Is BioScreen registered with FDA?
Yes, BioScreen is registered with the FDA and our registration number is 2027219.

Can BioScreen test controlled substances?
Yes, BioScreen is registered with the Drug Enforcement Agency (DEA) and can handle schedule I through IV drugs.  Please request a DEA form 222 to be sent to you prior to submitting any samples.

Can BioScreen test for asbestos?
BioScreen is currently not testing for asbestos.

Can BioScreen test for lead on paint?
BioScreen is currently not testing for lead in paint.

Why do test methods need to be validated?
Current Good Manufacturing Practice regulations [21 CFR 211.194 (a)] require that test methods, which are used for assessing compliance of drug 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.  Please inquire with our sales department regarding the cost of method validations.

I need to obtain a copy of an old report.
BioScreen can provide copies of archived report(s) when requested by the original client.  A minimum fee of $50.00 is charged for the retrieval and coping of reports.  Additional charges may apply depending on the quantity of records requested.

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 sample accession (tracking) number, project number and laboratory notebook reference number.

Can I obtain a copy of the test method?
Test methods, which are not proprietary, can be provided to the client.  All test methods can be reviewed on site during an audit of BioScreen.  If a proprietary method is requested by a Government agency, BioScreen will provide the method directly to the agency.  Minimal cost will be charged to the client for preparing and shipping these documents.  Please incur for charges.

Can I obtain copies of the raw data (notebook pages or chromatograms)?
BioScreen does provide cGMP data packages at a cost of 10% of the cost of the test.  Please indicate on the sample submission form that this is required.

How are reports issued?
Hard copies of the reports are always sent via US mail.  Please indicate on the sample submission form if you require a fax of the results.

Who do I speak to discuss the results on the report?
Please call BioScreen at (310) 214-0043 and ask for the department manager or supervisor.  Each report has a unique project number at the top left corner of the report.  We can then pull this report from the file and discuss any issues you may have.

Is BioScreen audited by the FDA?
Yes, BioScreen is registered and audited by the FDA on a periodic basis.

How do I schedule an Audit of BioScreen?
Onsite client audits can be scheduled through your salesperson or by contacting Maureen Levin our QA manager at (310) 214-0043 ext. 116.

Does BioScreen complete vendor surveys or paper audits?
Yes, Please fax your document to the attention of Maureen Levin at (310) 370-3642.

Is BioScreen ISO Certified?
Yes, BioScreen is certified to the ISO 9001:2000 standard.

Do you have more than one location?
BioScreen is headquartered in Torrance California. BioScreen Clinical Services is a division of BioScreen performing Human Clinical testing and is located in Phoenix, Arizona. 

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