Selecting the right Consulting service provider for any pharmaceutical organization is crucial to ensure that the company continuously produces quality products.

The relevant experience and expertise of a consultant can help with preparation for regulatory submissions, product development, clinical trials, and much more.

This article discusses the most important focus areas when selecting the right consultant for your pharma company.

You will discover:

What Does a Pharmaceutical Consultant Do?

A pharmaceutical consultant guides a company throughout all product lifecycle stages, including planning, designing, constructing, product testing, and commissioning processes.

Many consultants can also help you with very specific tasks like the implementation of eQMS software. They can also help you choose the best pathways for regulatory compliance and improve the quality of core drug development processes by providing guidance on GCP, GMP, and GLP.

Among areas where pharmaceutical consultants usually provide their expertise are:

  • Pharmaceutical firm business strategy
  • Quality Management Systems
  • Product Design & Development
  • Clinical trials
  • Pharmacovigilance
  • Regulatory Submissions

Key Focus Areas When Choosing the Right Pharmaceutical Consultant

The best pharmaceutical consultant for your company may be different depending on the goal of your project, company size, product lifecycle stage, and many other variables.

Therefore, you want to select the consultant that matches your specific needs most optimally. Below are listed the most important areas you should focus on when looking for the right pharmaceutical consultant for your firm.

Your Organization and Project Needs

Before you put consultants under the microscope, you should assess your needs and ask yourself the following questions.

Do We Want To Work With a Consulting Company or an Individual Consultant?

A consulting firm will help you by selecting the candidates for your project and present the most relevant consultants to you. On the other hand, if you want to work with an independent consultant you will have to do everything yourself – finding, evaluating, and choosing the right expert for your firm.

Why We Need a Pharmaceutical Consultant?

Nowadays, many pharmaceutical consultants provide a wide selection of services. At times such a variety of options can slow down your selection process. Therefore, you must specify all your project requirements from the start.

Ensure that roles, deliverables, and the timeline within your project scope are clearly defined. Explicitly defined project scope from the start will allow you to have a more meaningful interview process, and of course, will be useful when creating the consulting contract.

How Important Is Quality vs Speed in the Project?

If speed is the priority for your current project, then you will want to find a consultant who is used to addressing similar issues and who can get to work right away. If you have a complex project on your hands, the project scope becomes a much more important factor. Consider narrowing your project scope to complete a project within your timeline.

On the other hand, if the quality is your success factor, then you will have to select a consultant who is highly competent and can deliver at the level you require.

Expertise and Experience of the Consultant

Once you have successfully answered the prior questions you should have a better idea of what kind of pharmaceutical consultant would be the right one for you. At his stage, you should start assessing individual consultants and their level of expertise.

Does the Consultant Have Relevant and Recent Experience?

Ensure that the consultant’s area of expertise and knowledge of an industry matches the requirements of your project. Besides, check if the consultant has direct experience working with projects that involve a similar type of pharmaceutical product.

The consultant that has relevant experience and knows all the ins and outs of your industry and the product category has a higher likelihood of delivering high-quality results in less amount of time.

Has the Consultant Worked With My eQMS?

Today, consultants must be familiar with modern eQMS software solutions. So, put an effort into finding out what types of systems did the consultant work with prior, and how did it help drive success in similar projects like yours.

If your project revolves around the implementation or upgrade of an eQMS, you will want to work with a consultant who is knowledgeable of the best systems on the market currently. In this case, you can consider asking the consultant for eQMS recommendations.

If you already have a solid eQMS software solution, consider asking your eQMS vendor for recommendations. A supplier may also know some pharmaceutical consultants who are highly competent in your software and can produce quality results.

Does the Consultant Work in a Favorable Geographical Location?

You might also want to consider the geographic location of the consultant. If your project involves the consultant working at the drug manufacturing site, then you would need he is from your country or neighboring countries.

If your project allows for remote work, then of course the geographic location is less relevant. Although, you might benefit greatly by hiring a consultant who has expert knowledge of the local market conditions and requirements. Especially if that is the country where you want to market your pharmaceutical product.

Interviews With the Consultants

Interviews are an essential part of the consultant selection process. Here are some critical questions you would want to answer when conducting the interviews.

Has the Consultant Worked With Firm at Our Product Lifecycle Stage?

There is a difference between companies who have released products to the market and the ones that are just preparing to release the first one. If you are a small company that is yet to release a product to market you would need a consultant that is used to working in similar situations.

Such a consultant should be willing to educate you about all the necessary aspects when releasing the product to market. On the other hand, if you have already released many pharmaceutical products to market, you will not need too much assistance from the consultant. Instead, the best consultant, in this case, would be the one who is ready to start the work and produce results immediately.

What Are the Consultant’s Success Criteria?

When you are getting closer to making the final hiring decision, it is important to keep the overall view in mind. Remember one of the previous questions from above – “How important is quality vs speed in the project?”

Are you looking for a consultant who can quickly help reach compliance with regulations or you are looking for a consultant who can be with you for the long-term and act as a strategic partner?

If your goal is to define quality in your organization to differentiate among the competitors, then you want a consultant with a desire to quality across all the project deliverables. So, make sure that the consultant’s success criteria are aligned with yours.

What Other Services Does the Consultant Provide?

Sometimes, you might want to hire a consultant to assist you with a short-term project, for example getting through the next GMP audit.

However, after the project closure, you would want to pharmaceutical consultant and/or his colleagues to be capable of helping you in future projects. Therefore, it is important to recognize what other competencies does the consultant or a consultancy firm brings to the table.

Examples here could be other skills that the consultant possesses, as well as an established professional network. Many pharmaceutical service providers offer not only consulting services but also manufacturing, labeling, packaging, and distribution services.

Consultants Fees

At the end of the day, consultants’ fees should not be the only determining factor for selecting an expert. Ultimately, you would want multiple consultancies and/or consultants bidding against your project scope and deliverables. However, choosing the cheapest option may cost you more in the long-term if the work is not done properly and/or completed in time.

Typically, if you are looking for short-duration assistance from the consultant, it will likely be more expensive. You may find that smaller consulting firms, usually, offer lower rates. However, recognize the disadvantage here. Even though lower business operating expenses allow smaller firms and individual consultants to offer their services for lower prices, they also have limited capacity. This can be a problem if you realize that the need for a consultant’s capacity is greater than anticipated, or you decide to accelerate your project schedule.

Lists of Pharmaceutical Consulting Firms

Finding the right consultant for your drug manufacturing company can be tough.

Fortunately, we have done some research, and picked consultancies as well as some individual consultants located in different countries with different specializations. For the most part, we included small to medium-sized consultancies specializing within areas such as Quality Assurance and Regulatory Affairs, which also provide have expertise in a variety of other areas.

See pharmaceutical consulting firms from different countries:

Final Thoughts

Many pharma start-ups, as well as some small to medium companies, have great concepts but may lack experience in areas like Regulatory Affairs, Quality Assurance, Pharmacovigilance, and others. These tasks can easily be outsourced to specialized pharmaceutical consultants with expertise in such fields.

Although the right consultant will differ based on your specific needs, the article discusses the most important areas you should be focusing on when selecting the right consultant for your firm.