Qualification & Validation Charges

Hi to all,

I’m new to this forum. My line of work is in servicing and validations too. My question if I may ask is whether there exists a baseline in validation charges. I have seen contracts coming from Europe which are much cheaper than those coming from Asia. Others are exuberant and others are way too cheap that don’t cover standards solution costs. I believe that a validation comes with a standard that must meet FDA, and EP requirements to say the least! So can’t a validation charge based on the type of equipment, have a standard base price performed by anyone as long as they are certified to do so? I would really love to hear your opinions.

Kind regards


Let me be sure I understand your question. You’re shopping around for validation consulting work and seeing wildly varying prices / effort estimates?

I’d say that’s probably (unfortunately) all too common. Is there a standard price for consulting work? No. As with any purchased service, you need to understand what you need, confirm that the bidder is qualified, and ensure the scope is sufficient to meet your needs. If you’re purchasing such a service, you’re really saying “I don’t have internal expertise and so I need to go outside the organization for expert help.” Indeed, you want to find expert help and that ONLY comes with experience.

Some self-proclaimed experts may charge an exorbitant fee that is based more on their name than the quality of their work. Some unscrupulous types may low-ball the effort hoping to win the business and then start adding on things they neglected to mention.

When shopping for a consultant, get resumes, get references, and get an idea of what you’ll need. As a consultant, we don’t mind giving resumes and references but we get “exercised” all too often - companies will ask us for a quote and we spend time coming up with a quote only to learn that they just wanted something to compare against their incumbent’s quote. You can build up a bad name for yourself doing this so do your homework and understand your needs before asking for a formal quote. Forums like this can help serve as a sounding board for whether or not something in a quote is legitimate.

Hope I was close to on target regarding your question and I hope the above was somewhat helpful.