If you’re facing a quality or regulatory compliance issue that’s critical to your business and needs to be resolved quickly and effectively, you may be wondering whether to hire a consultant or handle it yourself. While both options have advantages and disadvantages, hiring a consultant can provide many benefits that can help you overcome your challenges and achieve your goals. In this article, I’ll discuss some of the key benefits of using consultants and how they can add value to your organisation.

What is a Consultant and What Do They Do?

Quality and Regulatory Consultants are experienced professionals who provide specialised guidance, advice, and assistance to clients regarding assuring the quality safety and efficacy of the medicinal product or medical device. They are typically renowned for their extensive expertise and experience in their field, which allows them to competently analyse, diagnose, and solve complex problems using their many years or decades of experience. Typically, consultants offer recommendations, propose solutions, and help businesses implement necessary changes.  In a regulatory compliance scenario, this may be in areas such as strengthening the QMS, training staff, managing risk, and making complex decisions on release of material or equipment.

Hiring a consultant can provide your business with several advantages, helping you resolve critical issues more effectively and efficiently. Often, it is more cost-effective to hire a consultant instead of using internal resources or hiring additional permanent employees.
Some of the main benefits of hiring a consultant include:

Unique Solutions

Consultants can offer you various benefits, including unique solutions that are customized to achieve compliance with minimal impact to cost or labour. They can fine-tune their approach and methodology to suit your needs, budget, and timeline. Additionally, consultants can bring fresh perspectives and insights that your organisation may not have considered to help you view your problem from a different angle and discover new opportunities to achieve the same quality and compliance goals.


One of the advantages of working with consultants is their ability to deliver quick results within a reasonable timeframe. Unlike internal resources that may be distracted by their everyday work or have additional duties, consultants can remain laser-focused on the task at hand. This ultimately ensures that the project is completed on time and to a high standard. The consultant will be solely dedicated to the project at hand, with the motivation to complete it quickly and effectively. Consultants are already equipped with the necessary skills and knowledge, eliminating the need for training or background reading to address your issue.

Knowledge of Best Practices

Consultants also offer their expertise in best practices and effective solutions within the industry. Because consultants often work with multiple clients across different product types and different regions, they will have knowledge of dealing with different competent authorities and regional and global approaches, which they can bring to your unique problem or project. This can help you to stay compliant and achieve your goals of continuous improvement of your quality system. They can use their experience and expertise to help you identify gaps, level up your performance, and implement the right solutions.

consulting team

Specific Skills

The next benefit of using consultants is that they can add specific skills to your organization that you may not have internally. For example, if you have never had to deal with a recall or defect notification or you have a warning letter or non-compliance statement due to non-compliance with a new regulation, you can hire a consultant who has the relevant skill set and experience to assist you. This allows you to access talent without hiring, training, or retaining staff and the longer your team works with the consultant the more they too will learn about the issue or regulations.

Creating Change

One of the most important benefits is their ability to help drive positive change within the organisation. Change can be a daunting task, requiring the implementation of new processes, technologies, and cultural shifts. Consultants can assist with this process by bringing in fresh perspectives, innovative ideas, and proven methodologies.  Consultants can ensure smooth day-to-day operations by providing ongoing support throughout the stages of the consulting process. This includes monitoring progress, identifying any issues or roadblocks, and adjusting as necessary to stay on track. By doing so, consultants can help organisations achieve their objectives and successfully navigate the challenges that come with bringing about the various changes that the consultant recommends for remaining in or regaining compliance.

the orion team

As you can see, hiring a consultant can offer you many benefits that can help you solve your business-critical quality compliance issue more efficiently and effectively. Consultants can provide you with unique solutions, speed, knowledge of best practices, specific skills, and creating change.
If you need help with maintaining compliance and ensuring your products adhere to the highest quality, safety and efficacy standards, Orion GXP Consulting has a network of highly professional consultants who can jump straight into your issue and provide immediate and cost-effective solutions.
Please feel free to reach out to us if this is a service you need – info@oriongxp.com or call +353(0)71 98 10101