7 Reasons to Hire Regulatory Consultants

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“Why should I hire a consulting firm? I can just do it myself!” This statement is often made without a complete understanding of the real value provided by Regulatory Drug Development Consultants (RDDC). An effective consulting firm is there to supplement your business proceedings, never to imply that they know better than you do.

In fact, there are a number of misconceptions that exist so let’s re-evaluate some of the often forgotten facts relating to effective regulatory drug development consultants.

  1. RDDCs have deep industry expertise.

    Consultants have the rare privilege of working with a plethora of different companies on a variety of projects ranging the entire CMC process, which gives truly remarkable insight into the best practices and what has historically worked and what has not. This knowledge gives consultants the ability to provide truly expert opinions and different opinions from the potentially limited scope of a single company.

  2. RDDCs can focus on the exact issues.

    Every worker is bombarded with a multitude of projects, deadlines, and meetings. Calendars are so full people often write calendars event to update the calendar. Between training activities, performance development plan deliverables, paperwork, and miscellaneous concerns, it’s no wonder things fall between the cracks. However, effective consultants bring a team specifically formulated to focus on the problem for which they were hired. Period. There are no office politics, jumping through hoops, or “he-said-she-said” fiascos. Consultants come in with well-defined project plans, clear deliverables, and a variety of analytical tools and resources that ensure their ability to succeed on time and on budget.

  3. RDDCs look at things in a new light.

    It is far too easy to get stuck in an endless loop of acceptance and agreement. Sometimes a new employee comes and questions things out of a lack of familiarity that causes some surprising reorganization. Consultants question things to help ensure you have the best methodology as well; not because they are unfamiliar, but because they are intimately familiar. Willingness to challenge the status quo and provide opportunities for growth and success is the biggest part of what a consultant does for you—aside from the work!

    7 Misunderstood Facts About Regulatory Drug Development Consulting
  4. RDDCs can be that specialized team.

    Specialized skills always come at a price. People who deeply understand risk management, serialization, validation, analytical processes, etc. do not generally just walk up and give you their knowledge. RDDCs spend years cultivating a team of people who have the specialized knowledge to tap into whenever it is needed. Because RDDCs work with your team on specific, key projects, you get the exact knowledge that you need to succeed.

  5. RDDCs can do it all.

    Due to the long and varied history, spanning countries, companies, functional areas, and leadership levels, it is not hard to understand why an RDDC would be able to fill in the gap you have. Providing assistance through resource allocation and valuable insight into any situation. Whether you are looking to hire a new employee, or need a small project maintained, consultants can fill in the gaps you require for as long as you need them to.

  6. RDDCs hire only the best.

    Just like your company hires qualified employees, consultants are seeking out the most well-rounded people to build their team. Some of the many benefits that you have access to when partnering with a high quality RDDC:

    • Scientific and technical backgrounds, analytical minds, problem-solving abilities, and strong negotiation and communication skills
    • Understanding the multidisciplinary complexity associated with the discovery, development, commercialization, and sustainability of a pharmaceutical product
    • High value-added function within a company that is critical to successful development, registration, approval, and life cycle management of pharmaceutical products
    • High visibility at all levels of the organization and to the regulatory agencies with whom they interact
    • Experience spanning the full range of the pharmaceutical industry, including working as biological or chemical scientists, engineers, lawyers, quality control and quality assurance staff, as well as in drug manufacturing and development positions.
    • Vested interest in the variety and challenges of the work and opportunities provided within CMC RA.
  7. RDDCs only use quantifiable data.

    RDDCs care about getting it right. The elephant in the room will be discussed, and the niceties of corporate politics are put aside to ensure that the best solution is found. RDDCs take data driven action and solve problems. By partnering with an RDDC, you not only ensure that the ideas you’re generating are backed up by numbers, you also ensure that the possible consequences have been minimized.

A great Regulatory Drug Development Consulting firm will help you grow sustainably. As you continue to delve deeper into the pharmaceutical space, more and more pieces can get lost. Don’t let things disappear and let someone do that thinking and watching for you. Meticulous care is the name of the game and RDDCs will always have your best interests in mind when planning and executing.