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General Fees and Policies
PRICES QUOTED ARE FOR U.S. DOLLARS OR CHECKS DRAWN ON U.S. BANKS
Published prices herein apply to most test samples; however, it is recommended that clients consult with the Nelson Sales department for a price quote on custom or large projects. Samples which require special handling, extra processing or manipulations may incur additional charges. Nelson Laboratories, Inc. will provide price quotations after evaluation of the samples and/or protocol, prior to initiation of the work. Prices include submission of a final report by U.S. Mail and maintenance of records and raw data as described in records retention below.
Prices are subject to change without notice. Price quotations valid for up to 90 days will be issued upon request by the Nelson Sales Department. Please refer to the Nelson Laboratories website for current pricing:
www.nelsonlabs.com.
Terms of Payment
Terms are net 30 days from date of invoice. Interest at the rate of 1.25% per month (15% annual rate) will be added to accounts past 30 days. A charge of $25.00 will be incurred for each returned check.
New Clients: A 50% prepayment is due for new clients before work can begin. The balance of the study cost is due after the analysis is completed but before results are sent to the sponsor. For projects that are large or extended (>3 months), partial or phase completion payments may be required. International clients will be required to submit full payment prior to initiation of each study.
Established Clients: With a current account, established clients are invoiced after their studies are completed and results are issued. Studies over $5,000.00 will normally require a 50% prepayment to help cover the initial set-up and test costs for these studies. Balances past due (over 30 days) must be brought current before new work will be accepted.
We accept wire transfers, checks drawn on U.S. Banks, or Visa, Master Card, and American Express credit cards. For questions regarding credit applications or wire transfer routing, please contact Nelson Laboratories’ Accounting Department at
accounting@nelsonlabs.com.
Discounts
Nelson Laboratories generally lists standard volume discounts in its published price guides. Negotiated volume-based price quotes and discounts will be reviewed by our Sales Department and are subject to change on an annual basis.
International Clients: Customs and Prepayments
Due to recent U.S. FDA and U.S. government regulations, international shipments require specific documentation to ensure timely receipt at the laboratory. Please be sure to include:
- A completed Sample Submission Form with your product/samples
- Be sure to note “SAMPLES FOR ANALYSIS & NOT FOR HUMAN USE” on the product description of your airbill or shipping documents. This will help U.S. customs clear your product for shipment to the laboratory with minimal delays.
- All shipments sent to Nelson Laboratories from outside the United States must pass through U.S. customs. There will generally be a cost associated with shipping to/from Nelson Laboratories that cannot be determined until the shipment arrives.
- Please note that all US and International Customs Fees, Taxes, Tariffs and related costs will be billed to the client on the final invoice. Full payment for lab services must be received prior to initiation of testing.
GLP Studies and Fees
Final reports intended for submission to the U.S. Food and Drug Administration (FDA) or the U.S. Environmental Protection Agency (EPA) in support of a marketing request may need to be conducted under the current Good Laboratory Practices (cGLP) regulations of the specific agency. Sponsors should notify the laboratory prior to initiation of such tests and this should be done on the Sample Submission Form checkbox for GLP / Non-GLP. Additional charges apply for all GLP studies. Large studies will incur standard GLP fees or a 15% GLP fee, whichever is greater.
All GLP fees are per study type:
FDA GLP study fee (U.S. clients) ............................................. $ 275.00 or 15%, whichever is greater
EPA GLP study fee (U.S. clients).............................................. $ 375.00 or 15%, whichever is greater
FDA 510(k) and other regulatory submissions should include a predicate with a current 510(k) or other regulatory approval. It is the responsibility of clients to consult about their test plan with their FDA or regulatory reviewer for all 510(k) and other regulatory submissions prior to testing.
GLP studies must be pre-approved by both the sponsor and the laboratory, performed according to a specific protocol, recorded on the GLP study master schedule, and inspected by the quality assurance department. Nelson Laboratories complies with all phases of the FDA and EPA GLP regulations. If you are required to submit final reports in a specific format, please note your request on the Sample Submission Form when remitting samples to the lab for analysis. If you need additional assistance, please contact Client Services at
clientservices@nelsonlabs.com.
STAT Fees (Expedited Studies)
STAT fees are for expedited testing and are an additional 50% (up to 100%) of the test invoice (minimum fee, $50.00). STAT fees compensate for requirements to interrupt generally scheduled tests, expedite material purchases, or may require staff overtime, after-hours, weekend, or holiday work situations. STAT requests are typically indicated by the STAT checkbox on the Sample Submission Form. Weekend or holiday STAT fees may be billed at twice the normal STAT rate and will be quoted to the client where applicable.
STAT requests will be honored when capabilities permit. Due to compendial test method requirements for incubation and other time or scientific constraints, some tests may not benefit from STAT requests. Where possible, please consult with the lab in advance regarding STAT studies and turnaround time expectations.
Controlled Substances and Hazardous Materials Handling Fees
A minimum fee of $250.00 will be charged for each shipment of controlled substances received for testing. Pre-notification of all controlled substance shipments and appropriate documentation are required for regulatory compliance. Hazardous materials that cannot be returned or easily disposed of will incur an additional charge of at least $50.00, but will vary depending on the amount and type of disposal required. Please contact the Nelson Sales Department prior to shipping controlled substances or hazardous materials to the lab.
Cancellation Fees
A purchase order and full payment for partial billings is required where the client has requested initiation of a study and subsequently cancels the study. In order to cover administrative costs, a charge of $25.00 is assessed at the time a study is cancelled in addition to any work already completed on the project.
Shipping and Special Handling Fees
At the sponsor’s request, samples can be returned after testing. All samples will be shipped via UPS Ground unless otherwise specified. A general pricing guideline is outlined below:
Minimum Charge: ....................................................................... $ 6.00 + shipping cost
Minimum Special Handling Fee:............................................................ $ 25.00 + shipping cost
Some samples require special handling/packaging in order to ship them without damage. In such cases, we will charge a minimum of $25.00 plus the shipping cost to return the samples. This fee may increase due to the amount of samples and time spent preparing them for shipping. Please contact our shipping department if you have any special requirements or specifications for sample return.
On-line Report Access, Duplicate Original Reports, and Fax Copies
As a value-added service to our clients, Nelson Laboratories provides an on-line, secure site access to final reports at
https://secure.nelsonlabs.com. Generally final reports are available on the secure site for download (PDF) before the hard copy is mailed. To activate your on-line account please contact Client Services at clientservices@nelsonlabs.com.
Requests for overnight delivery, additional original copies of reports, sample returns, and archiving of samples will be honored. Charges will be incurred accordingly. We generally do not charge for periodic requests for a fax or e-mail report.
On-site duplicate report or raw data....................................................... $ 25.00
Off-site duplicate report or raw data...................................................... $ 60.00
Amended report ....................................................................... $ 75.00
Photocopy of recent report................................................................... No charge
PDF copy of recent report.................................................................... No charge; available on secure client site
Additional charges for protocol studies and special projects will be quoted separately
Protocols
Protocols are issued upon request to clients who intend to submit samples to the laboratory. A purchase order number must be submitted for requested protocols when samples have not yet been submitted. All protocols that are issued and have not been used in testing within three months from the day the protocol was sent will be billed. If samples are sent within a year of the original issue date, the amount billed will be credited to the final invoice.
The protocol fee compensates for staff time in preparing and issuing protocols, however, billing for protocols is not a transfer of intellectual property or rights owned by Nelson Laboratories.
Consulting Services
Nelson Laboratories, Inc. offers consulting services for various test services and on-site services (minimum of $120.00 per hour). Our services include biocompatibility, sterilization validations, cleanroom procedures, bioburden control, environmental control, barrier testing, filter validations, packaging material validations, FDA and EPA regulations, etc. Contact the Nelson Sales department for a consultant quotation and to determine the appropriate staff member(s) for your project.
Record and Sample Retention
All data will be saved for ten years, or as required by law, with a backup computer optical image. File storage beyond ten years will be billed at an annual rate of $30 per study. U.S. FDA typically requires retention of samples for five years. U.S. EPA typically requires retention of records and specimens for ten years, but in many cases they may need to be retained for the market life of the product and are the responsibility of clients.
It is the policy of Nelson Laboratories to return all GLP samples to the client. However, if you elect to archive such samples at Nelson Laboratories, you will be billed $100 per year for solids (non-toxic) and $200 a year for liquids.