We'd love to collaborate with you!
It's a straightforward process but the devil is in the details.
Here's a guide:
Q. Who can I speak to about my testing needs?
A: We have a wide variety of scientists who specialize in different types of experimentation and analysis. For various types of projects the phone number for the subject matter expert is below.
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Analytical and Materials Testing Info or Quotes:
+1 765.588.5641 -
Solid-State Screening and Selection Info or Quotes:
+1 765.588.9538 -
Amorphous (Non-crystalline) Materials Analysis and Development Info or Quotes:
+1 765.588.5632 -
Method Development & cGMP Testing Info or Quotes:
+1 765.588.5641 -
Intellectual Property Support Including Conflict Checks:
+1 765.588.9538
Q. What legal documents should be in place before we share confidential information?
A: There are several documents that can be put into place depending on your corporate needs. The first is a mutual confidentiality agreement (MCDA). We'd prefer to start with your corporate template. Review usually takes 48 hours or less. We can also implement a Master Services Agreement (SOW) and a Work Order prior to commencing a project if your purchasing department requires it.
You can request a document review by clicking here.
Q. What types of payment do you accept?
A: Typically companies will issue purchase orders (POs) before a project begins. When an invoice is sent you can pay with check, credit card, ACH, or wire transfer to our bank. We require a PO or a valid credit card before work begins.
Q. Do you accept potent compounds?
A: Yes, we accept all levels of potency with the exception of those requiring full containment. We will first review your SDS and determine if we can handle the material. Generally if you have an LD50 value we will evaluate that or calculate one. We can handle up to SafeBridge Category 3 (OELs 30 ng/m3 to 10 ug/m3, however, for Category 3 materials, we will review each SDS and make a decision. For highly potent material (Category 4 with OELs 30 ng/m3 or less), we would not be able to accept the compound. If you have a question about whether we can accept your compound, please click here.
Q. Do you handle controlled substances?
A:Yes, we handle DEA schedule I-V controlled substances. Some controlled substances require a 222 form prior to shipment. Please contact us if you need to submit controlled substances (click here).
Q. Do you offer GMP testing?
A:Yes, we offer most tests (e.g. TGA, DSC, XRPD, KF) in GMP format (QC audited). We also offer method validation and release testing (COA issuance). For more information on which tests are available, turnaround times, and pricing, please contact us (click here). We are registered with the FDA, DEA, and HealthCanada and have been audited by the agencies with no findings and no 483s.
Q. Do you conduct testing for consumers? OR I found a pill in my son's/ daughter's/ girlfriend's/ boyfriend's/ wife's/ husband's, etc. possession - what is it and do you test for unknowns?
A: The short answer is "maybe". In general, the analytical testing we do is for pharmaceutical companies and other chemical development companies. We do test unknowns and possible counterfeit drugs and have done so for consumers, although there are quite a few caveats when it comes to this area. First, if it's illegal to have whatever it is you want tested, we likely can't do it without a police department or court being involved (e.g. criminal complaint testing). Second, if you don't know what it is, send it to us, and it turns out to be an illegal or controlled substance (e.g. oxycontin, heroin, Ecstasy) then we are required to notify the authorities which may result in criminal charges for the person who had possession of the material.
If you simply what to know the identity of some pill you found try these resources first:
Pill identifier databases:
https://www.drugs.com/imprints.phphttps://www.webmd.com/pill-identification/default.htm
Some other points:
- If you bought the meds on the INTERNET without a prescription (Rx), there's a VERY high likelihood they are fake or contain little to no active ingredient.
- Testing for "weird smells" or odors is incredibly complex and not something a consumer can usually afford.
- We don't test for asbestos, drugs in urine or blood, mold, diseases, water contamination, or food-born bacteria .
If the above fails, contact us an we can give you some other resources or a quote (click here).
Q. How much material is required for typical testing?
A: It depends on the technique. For most analyses, such as XRPD, DSC, TG, DVS, etc., 25 mg is enough. For standard polymorph screening or salt selection projects, 3-5 grams is requested. Otherwise, the amount required depends on the nature and scope of the project. Quantity of sample required for each test (XRPD 50-100mg, DSC/TGA 20-30mg, DVS 10-20mg, KF 100mg, IR/Raman 20-30mg, solution NMR 10-20mg, solids NMR 0.5g-1g, particle size 1-2g for method development, 0.5g-1g for testing)
Q. How long will it take to complete the project?
A: For standard analyses non-cGMP analyses, we offer 3-5 day turnaround and depending on the technique, for an small additional cost, 48 or 24 hour turnaround. For standard polymorph screening and salt selection projects, 4-8 weeks is typical and depends on our current project load. Abbreviated screens are shorter in duration and extensive screens take longer.
GMP analyses take slightly longer depending on the test duration, volume, and complexity of analysis. Typically 10 business days or less. Rush service is available on some GMP tests (e.g. XRPD, DSC, TGA). Call for details.
Q. Can we begin the project immediately?
A: Typically the answer is yes, but sometimes our current project load pushes project start times out a couple of weeks. We will give you an accurate answer when a project request is submitted since our queue is constantly in flux.
Q. What is the typical project flow from request to finish?
A: We will review the chemical structure and relevant property information first. Based on the information reviewed, we will prepare a detailed proposal that states goals, deliverables, turnaround time, cost and material requirement. There are usually a few reviews and modifications. Once the proposal is accepted
Q. Are you registered with and have you been audited by the FDA?
A: Yes, and Yes in 2016. There were no findings, no 483's. We are also audited regularly by the DEA and clients. We are registered with HealthCanda and have an audit scheduled in 2020.
Q. What other agencies are you registered with?
A: Health Canada. We expect to be registered with the The Medicines and Healthcare Products Regulatory Agency (MHRA) shortly (2020)
Q. Are clients able to audit you?
A: Yes, of course. With advanced notification you are welcome to visit and audit our quality systems. If you have questions regarding our quality systems, click here.
Q. Do you have a quality agreement that you provide to your clients?
A: No, in order to meet your specific needs, quality agreements are drafted by our clients. Our QA Department will work with you to make sure your individual needs are addressed. Feel free to contact our QA Department at +1.765.588.5622 or +1.765.588.9537
Q. How do I submit samples for testing.
A: If you have a quote, fill out the Sample Submission Form (click here). The address is on the form. Please reference your quote number on the SSF. If you don't have a quote, please obtain one by clicking here.
Q. How long does it take you to review legal documents, send quotes, and answer my questions?
24 hours or less. It's corporate mandate and our employees are rewarded for exceeding response expectations. If you don't receive an answer please call Shawn Comella our CEO at +1.765.588.5624 or email him at rfi@triclincilabs.com