General FAQs

Do you have more than one location?

BioScreen Testing Services is headquartered in Torrance California.  BioScreen Clinical Services, a division of BioScreen performing clinical testing, is located in Phoenix, AZ.

Is BioScreen ISO Certified?

Yes, BioScreen is certified to the ISO9001:2008 standard by SAI Global. Our certificate number is CERT-0077723.

Does BioScreen complete vendor surveys or paper audits?

Yes, Please submit your documents via fax to the attention of RaShaune Johnson at This email address is being protected from spambots. You need JavaScript enabled to view it. .

How do I schedule an audit of BioScreen?

Onsite client audits can be scheduled through your salesperson or by contacting RaShaune Johnson, our QA Director, at (310) 214-0043 or This email address is being protected from spambots. You need JavaScript enabled to view it. 

Is BioScreen audited by the FDA?

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

Is BioScreen registered with FDA?

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

Does BioScreen follow FDA regulations?

Yes, BioScreen follows Current Good Manufacturing Practices (cGMP) 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 GLP?

BioScreen performs testing per GLP requirements at the request of the client. GLP requirements are covered in CFR section Title 21 part 58. Please request a quotation for the additional charges that will incurred for GLP testing. This request must be made prior to the start of the study.


 

Testing FAQs

Can I obtain copies of the raw data (notebook pages or chromatograms)?

BioScreen provides cGMP data packages at an additional cost of the test performed. Please indicate on the sample submission form that this is required.

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 inquire for charges.

Why do test methods need to be verified or validated?

Current Good Manufacturing Practice (cGMP) 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.

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.

 

Order & Payment FAQs

How can a company establish credit with BioScreen?

A blank credit application will be sent to all new clients. Please complete the credit application and return it to BioScreen. It takes approximately 2 to 3 weeks to process the completed credit application. Please note that we require prepayment for all new accounts for the first three projects, even if the credit application has been approved.

How do I pay for testing?

BioScreen requires pre-payment via check, money order, credit card (Master Card or Visa only) or wire transfer until credit is established.

How do I get a price quotation?

Please email This email address is being protected from spambots. You need JavaScript enabled to view it. 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 and clinical testing requests.  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 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 start testing with BioScreen?

You can contact BioScreen via email This email address is being protected from spambots. You need JavaScript enabled to view it., 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 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 for the courier you wish us to use (FedEx or UPS).

How do I submit samples to BioScreen?

Samples should be shipped to BioScreen Testing Services to the attention of the “Sample Receiving” department.

BioScreen Testing Services, Inc.
Attn: Receiving Department
3892 Del Amo Blvd, Suite 703
Torrance, CA 90503

All samples must have a signed sample submission form indicating the tests requested. All microbiological, chemistry and clinical samples are to be shipped to the above address.

Receiving hours are 7 am to 6 pm Monday through Friday (excluding Holidays).


 

Reporting FAQs

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.

How are reports issued?

Hard copies of the reports are sent via US mail or if the client wishes to online using the Biosecure system. Please indicate on the sample submission form if you require a fax of the results.

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.

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 fee will be charged for the retrieval and copying of old reports.  Additional charges may apply depending on the quantity of records requested. Please note that reports over 7 years old are destroyed and will not be available.