The Changing Face of Regulatory Affairs Consultancy

 

As the need for regulatory affairs consultants has escalated in recent years, many drug and device manufacturers have found themselves short-staffed or in need of guidance in an area of expertise that’s beyond the scope of their full-time staff. Usually, the need for additional staff is temporary, existing for the duration of one of more phases of the development processes – and hiring a regulatory affairs consultant is an ideal solution to span the gap.

Companies that have never worked with a regulatory affairs consultant in the past may wonder about the approach consultants take to their work duties. Just what are the goals and objectives of these consultants? The answer is simple: they have the same goals and objectives as a highly-qualified full-time regulatory employee plus more.

Like full-time regulatory affairs professionals, consultants adhere to a strict code of ethics that holds them to high levels of honesty, objectivity, and integrity. Their number one priority is to ensure the processes they oversee remain in compliance and with an emphasis on quality assurance at all stages of development. But it’s that “plus more” that makes hiring a consultant an especially attractive option for companies of all sizes.

Unlike employees who work for a single company, experts hired through clinical Resourcing companies can never rest on their laurels. While a full-timer may have a long and robust history with their employer, consultants have to establish themselves and demonstrate their levels of expertise with each new client, and that means they have to bring their ‘A Game’ to the table with every new assignment.

Remember what it was like when you were a new employee during that initial probationary period where you did all you could to ensure you excelled at all your duties and won your employer’s approval? That’s an everyday reality for consultants. That mindset also keeps consultants hungry for information and knowledge to keep abreast of the most current developments in the regulatory industry.

What’s more, because they’re not tied to a single company, consultants aren’t bogged down by corporate dogma; that means they can bring novel insights and approaches that might have been overlooked by your full-time staff. Innovation is at the heart of drug and device development; adding a fresh voice to even the most tried-and-true development protocol can have a positive trickle-down effect for your entire company.

So the next time you need to cover a labor shortage – or if you just want to bring some fresh ideas into your development process – consider the clinical outsourcing benefits that hiring a regulatory affairs consultant can bring to your company.

- See more at: http://www.trioclinical.com/blog/the-changing-face-of-regulatory-affairs-consultancy/#sthash.v17UHdkU.dpuf