Bertrand Clinical Label

Buffalo, NY

716-631-9201

We Respect Your Timelines.

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Audit

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WE MAKE AUDITING OUR COMPANY FAST AND EASY

We are very proud of our facility and embrace QA audits. We don't understand how anyone would feel differently because QA audits provide free consulting on how to improve our QA operations. We understand that you have a busy audit schedule so we want the process to be fast and easy for you and your company. 

  • Our facility is a true 10 minutes from the airport.  There is virtually no traffic in our area. 
  • We are happy to pick you up and drop you off at the airport if that makes it easier for you. 
  • We have a dedicated audit area and will have all the requested files sitting there ready for you to review. 
  • Depending on the location of your company, many auditors will fly in and out the same day. 
  • Call or email QA Manager, Dave Nitecki for your next audit. 716-631-9201 or daven@bertrandclinicallabel.com.
  • We have listed the recommended hotels below that are near the airport. 



The airport also has the following more budget-oriented hotels nearby - Holiday Inn Express, Days Inn, Best Western, and Quality Inn.


QA Manager Dave Nitecki






"Call Dave" (QA Manager, Dave Nitecki) to schedule your next audit.

716-631-9201 or Daven@bertrandclinicallabel.com. We look forward to seeing you. 



    

 



Frequently Asked Questions

Can we audit your facility before placing an order?

Absolutely. We welcome on-site audits and enjoy having customers inspect our facility. Contact Dave Nitecki at 716-631-9201 to schedule your visit.

How often are you audited by pharma and biotech companies?

We are audited a minimum of 5 times per year by pharmaceutical and biotech partners. Our QA program has been audited over 100 times in total.

What quality standards does your facility follow?

Our quality program is based on FDA cGMP as defined in 21 CFR Parts 210 and 211. We maintain robust SOPs, validated equipment, and computerized verification systems.

Do you offer virtual audits?

Yes. We can accommodate virtual audit requests and provide full documentation packages to support your vendor qualification process.

What documentation is available for audit purposes?

We provide SOPs, equipment validation records, and quality program documentation as part of our standard audit support package.