Developing an effective regulatory strategy is more than following the step-by-step requirements outlined by a regulatory agency. It’s a proactive process that helps you refine your product development goals and get your product to market faster. With the help of an experienced regulatory strategist, you can create a plan that addresses potential competitors, various regulatory requirements at different project stages, and more. Read on to learn more about what a regulatory strategy is and how to build one from start to finish.

Quality managers everywhere will attest to the fact that effective document control is critical to the quality management systems — a process that is central to any regulated organization. And depending on just how efficiently document control is done, it can either make or break the company. 

Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requirement. By collecting evidence and evaluating it objectively, a company can determine how well its quality management system is performing, and support an environment of continuous improvement. 
An effective audit can identify areas of risk and opportunity. Even if the audit doesn’t reveal any potential problems, it evaluates whether or not  you have an efficient QMS that is functioning as it should.

Many executives only see internal audits as something that has to be done for compliance reasons. However, the reality is that an efficient and effective internal audit program can reduce redundancies, reduce risk, enhance customer satisfaction, and bring about cost savings. An effective internal audit will also improve efficiencies by identifying opportunities for improvement and eliminating unnecessary or unproductive activities.   

According to a recent survey by the Independent International Organization for Certification (IIOC), 38 percent of total audits (across 22 certification bodies) were delivered remotely in 2020. The year before, that number stood at a meager 1.75 percent.  

Many startups mistakenly believe that creating a successful QMS strategy means building complex solutions to satisfy all elements of ISO 9001:2015 (or similar systems). Such an approach can be overwhelming, time-consuming, and even counter-productive. Quality management systems should be tailored and scaled to the specific business needs.   

Medical devices undergo a strict and rigorous evaluation by the Food & Drug Administration (FDA) to obtain approval for the US market. Suppose you want a Class II medical device cleared for sale in America. In that case, you need to be familiar with predicate devices (predicates) and how to support your substantial equivalency claims with carefully crafted documentation. 

The saying “an ounce of prevention is worth a pound of cure” is especially applicable when talking about prevention vs. detection in quality control. Estimates show that it is ten times more costly to correct a problem than it is to prevent one. Poor quality can result in additional business costs such as lost customers, wasted materials, product recalls, reworking the product, and cost of replacements and refunds. 

Maintaining oversight and control of your supply chain is a critical part of your organization’s quality management system.  Effective and efficient supplier audits can have significant impact on long-term compliance profile and profitability. The quality of the audit doesn’t just depend on the auditor’s skills – preparation, contribution, and support by the audit sponsor is also essential.

As product developers work to bring new concepts to reality, a regulatory affairs professional should be at hand to advise the team on effective regulatory strategies to get the product past regulatory authorities such as the FDA. However, choosing the right external regulatory affairs expert for your company can be a challenge due to the experience and expertise required to deliver the best possible results.