When you need an industry expert's advanced skills on an occasional or temporary basis, sometimes it may make more sense to contract with them, rather than hire them as full-time employees. 

Savvy C-level execs at the most prominent organizations know that if your QA or compliance struggle is only intermittent or short term, contracting is an excellent resourcing option. 

In many situations, contracting with an outside expert is superior to hiring. From issues of QA to compliance, new sterilization techniques and bandwidth struggles resulting from compliance to emerging regulations, the hurdles your organization faces are many. 

Temporary Lack of "Bandwidth" 

Your regulatory and quality assurance crews already have enough on their plates, and regulatory codes are always being updated around the globe. 

When the mental resources of your QA team are stretched that far, it's time to bring in some extra bandwidth. Otherwise, you face the risk of costly errors and employee burnout.  

• It's no secret that overburdened employees feel burned out faster. 
• Per Pharmamanufacturing.com, about 50% of regulatory affairs and quality assurance suffer from burnout. 
• Regulatory affairs and QA departments typically have very full workloads. 
• Contracted experts can help ease the backlogs and surge needs on a temporary basis.  

And, from time to time, significant but temporary projects can arise where supplemental resources are necessary in order to address man-hour demands.  

Every executive — and likely every employee — in our field has experienced the crunch associated with an understaffed workplace. Contracting with experts is one way to relieve that burden.  

Complaints 

A backlog of complaints can have a morale-diminishing effect on your full-time staff and create significant compliance risk. You'll find that a contracted expert can help relieve those complaints and avoid draining your top talent's time and energy.  

QMS Remediation 

Professional technical advisors can also be helpful when upgrading or developing a Quality Management System (QMS). 

A great QMS plans, controls, and improves all the elements that affect final product. Ultimately, an effective and efficient QMS impacts the end-user experience and their satisfaction.  

• QMS should ensure robust and repeatable control. 
• Your QMS can help you be compliant and reduce errors.  
• If you need bandwidth or specific technical expertise in developing or optimizing your QMS, you should contract with an experienced technical advisor.  

Regulatory Changes 

The pharmaceutical and medical device industries are ever-changing landscapes. New regulations and standards are regularly developed and existing regulations evolve over time. You can ensure your staff is ready for the change when the time comes by contracting with experts in the field.    

Lack of International Resources 

Supply chains span the globe. Sometimes resources — boots on the ground — are essential, especially when these resources have specific language skills, an understanding of local market regulations, and a good grasp of the local culture.  

• In the wake of COVID-19, we expect far more stringent rules and restrictions to arise in regions that were once less-regulated. 
• When you need supply chain audits, a contracted expert can help. 
• Savvy advisors can compare, contrast and smooth the compliance processes from one regulatory body to the next.  

• It's often better (more efficient and cost effective) to hire local experts on a temporary basis for specific deliverables.  
• Bringing on local-market experts means avoiding costly and potentially unsafe travel. 

Training 

Whether you're introducing new technology to your team, implementing a new tool or process, or only looking to improve output, your employees need quality training.  

In the medical device and pharmaceuticals realm, quality employee training affects more than employee retention rates. It's often a requirement for compliance.  

Contracted experts can conduct audits, and train your teams on: 

• ISO standards 
• Quality Management Systems 
• Changes to regulatory standards or approval processes — in the US and around the globe 

Training is all about improving the abilities of your current team. 

However, experts who deliver training will only be needed on a temporary basis when it comes to learning new standards and practices. That means it is far more affordable and convenient to engage a contract resource to deliver your training. 

Medpoint: A Global Network of Experts at Your Fingertips 

Here at Medpoint, we offer unparalleled advisory services in QA, regulatory compliance, and clinical affairs. Our mission is to provide experience and technical expertise at competitive rates and global availability.  

Whether you need help ensuring your QMS is compliant or training your employees to current standards, global network of experts is ready to serve you in North America, Europe, Latin America and Asia. To learn more, contact us for a no-obligation consultation.