Seven Things to Consider When Selecting a Pharmaceutical Quality Consulting Firm

Tommy McMaster |

Selecting a pharmaceutical consultant to help your organization with GMP, quality and compliance concerns can be a daunting task for any Quality executive. This is especially true for new or smaller companies that do not have existing relationships with consulting firms or solo consultants. The sheer volume of options in 2019 can make your head spin!

Selecting the right pharmaceutical quality consulting firm is often one of the most important decisions an executive will make, mostly because projects in this functional area are so critical to a company’s business performance, and a project’s success is contingent on the selected firm’s competency and ability to achieve desired outcomes.

While there could be dozens of factors to consider prior to making a selection, the following are the seven key topics we believe will help to ensure your company chooses the most qualified, “best fit” consultant for your business and specific FDA quality and compliance concerns.


Most pharmaceutical quality consultants have a section on their website dedicated to case studies or client testimonials. Taking the time to read through reviews and case studies is critically important and should be reassuring.  Look for companies, FDA-regulated products or compliance problems that are similar to yours, and investigate how the consultant handled the problem and if the solutions and practices they deployed could benefit you.


Ensuring a consultant’s expertise is in line with your needs is paramount.  Identifying firms that will consider your unique business model, organizational structure and culture is important for optimal outcomes.  For example, some consulting firms prefer checklist or “check the box” solutions which don’t take into considerations the company’s operating model.  This sort of approach often results in solutions that require layer upon layer of checks and rechecks, after which the firm announces, “problem solved” and moves on.  By comparison, the best firms aim higher and help clients make “step-changes” in regulatory, compliance and business performance outcomes.  With so much nuance in the pharma industry, be sure to research and see if a consultant’s mindset and skills are congruent with your organization’s needs. We suggest looking at the consultant’s portfolio of similar work, work history, references and educational background.  Often, this can be done via LinkedIn or the consultant’s website.


If a consultant is regularly featured as a speaker or moderator at industry events, it’s safe to say that they’re a respected member of the pharmaceutical GMP and compliance community. Most of FDA-regulated industry’s key events and conferences publish a list of speakers, usually with a corresponding biography.  Here is a good example from a recent FDLI conference. Take some time to browse through these sites to learn more about the potential consultant and/or the executives and practice leaders of the firms you are considering.


Trade associations such as ISPE, PDA, FDLI, RAPS, ASQ and others are important clearinghouses for professionals to maintain currency in their knowledge and ability to solve problems.  Make sure you inquire how often the consulting firm participates with the various organizations.  There are so many different aspects and facets of pharmaceutical quality and compliance operations that good consultants need to be involved in multiple organizations just to stay current.   Active organizational participation is key when you are evaluating consulting support and problem resolution.


Does the consultant your considering have helpful resources, and/or online resources that would show that they can develop tangible solutions to recurrent problems?  We always suggest perusing through any online resources provided by the consultant.  Examining offerings and solutions developed by the consultant can give you great insight into their core competencies. We’d also suggest searching for consultants by name on YouTube. If they’ve ever been a featured presenter or moderator at industry events, you can usually find the corresponding video. Being able to put a face to a name can be very reassuring. You’ll also get a glimpse into how that individual communicates, which could help you make the best decision for your organization.


Your professional network is a good resource.  Experienced pharmaceutical executives have most likely worked with dozens of consultants during their career and will be happy to give you insights into specific firms or individuals. Don’t be shy about reaching out to people in your network to gather intel and references.  If you ask enough, you’ll find out which consultants are actually solving problems, and which consultants are relying on old, tired and outdated approaches to quality and compliance challenges.


An in-person interview is usually the best way to find out if the consultant is someone you want to work with. Be prepared to ask pointed questions.  Examples of questions you might ask include:

  • “Describe your work process? How would you work with our staff, executive management and maybe other consultants?”
  • “What strengths do you possess that will prove particularly helpful in connection with this project?”
  • “What problems do you anticipate as we begin to work together? How can we best address these problems early on?”
  • “Tell us what you already know about our company and our potential needs?” Or in other words, “Have you done any homework on our company?”

Once asked, pay attention not only to their answers – but also their personal manner and professional style.  Ask yourself and your team, did the consultant really listen to our concerns, or were they more interested in talking about themselves?  Does the consultant “get us?”  Are they in synch with our organization’s mission and organizational structure?

But remember, if you have only a small, well-defined project, a phone interview or web conference may be enough.

Bonus Tip:  Before you start your search, you can save yourself a lot of time and hassle by ensuring that your project goals are well defined. You should develop a request for proposals that clearly states the budget, time constraints and outcome you expect. This will help both you and the consultant determine whether the consultant is a good match for your organization

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