Tip – Check Out Your Vendor Quality Before Signing the Deal
March 15th, 2013 // 3:28 am @ marquee
March 15, 2013
It’s very important to check out your dance partner before you go to town with him or her, according to our business associate and quality agreement expert Alan Minsk, Arnall Golden Gregory LLP. And if you are a pharmaceutical company that is going to enter into a deal with a contract manufacturer, remember this –
You need to do your due diligence first! You will want to at least check out that they are FDA compliant, are financially stable and can do the job. You may want to subject them to your own GMP compliance audit before you proceed. Remember that some countries do not have the regulatory oversight of the US, so FDA may become suspicious of your business partner.
It’s true that some compliance information is available on contract manufacturers. But if you deal with FDA much, you know that it can take months and sometimes years to get these documents from the agency. So, you should ask right from the start from your partner if they are fully FDA compliant.
You might run into a situation where the company does not want to show confidential information, or data that could be related to another customer. In that case, you may want to create a confidentiality agreement with that company.
For more interesting information on contracting with other companies, check out our upcoming Webinar, Avoid Warning Letter Disasters With a Strong Contractor Quality Agreement. He’ll give you a ton of details on what your quality agreement should include, such as 24 potential table of content areas for your contract, and a lot more.
