In today's rapidly-changing marketplace, drug and device companies of all sizes are realizing that a product’s time to market—and resilience once there—depends in large part on developing and executing effective regulatory and quality assurance strategies.
Investors are increasingly expecting streamlined, effective production processes that minimize rework, making quality absolutely essential. This, in addition to the rise in outsourced manufacturing forces manufacturers to comply with complex set of regulations—again underscoring the need for quality across the board.
Significant regulatory changes such as the transition from Europe's Medical Device Directive to the Medical Device Regulation require companies to undergo major revisions to their policies, processes, and systems in order to meet new requirements.
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All of this has led manufacturers—both big and small—to rely heavily on the third party compliance quality assurance consultants to help internal teams understand new regulatory initiatives, assess their current state against those requirements, and employ best practices learned from firsthand experience to plan and implement the actions necessary.
While some circumstances clearly underscore the need for outside expertise, the value of engaging a consultant, both financially and operationally, may not always be apparent. To avoid wasted time and budget—and potentially serious quality and compliance problems that could otherwise be avoided with the help of an experienced consultant, we've summarized a few of the major ways companies realize the benefits of bringing in an expert.
1. Answer Complex Regulatory Questions and Navigate New Regulatory Territory
While new regulatory challenges impact both drug and device companies, the device industry in particular is contending with sweeping new requirements on top of an increasing number of combination products which present complex regulatory issues of their own (regulatory authority jurisdictions, pre-market submission types, clinical trial design, multi-center review, etc.).
Third party experts who specialize in specific domains are very often relied upon to step in and help internal teams navigate these complex areas.
The benefit in this case isn't lost when the consultants leave. In addition to leading audits and conducting remediation and revision projects to bring a company into compliance with new requirements, these individuals offer unique and often indispensable training resources that give internal teams the insight needed to implement and maintain new processes, procedures, and systems well after the consultant's work is done.
2. Prevent the Costs of Enforcement and its Expensive Aftermath
Increased regulatory compliance enforcement over the past few years has led to an explosion of new codes while underscoring the importance of putting effective compliance safeguards in place. The costs of these preventive measures are almost always far less than the expensive consequences of enforcement action.
In addition to the disruption and costs of an investigation itself, resulting settlements, subsequent multi-year reviews, effectiveness audits, and related litigation from shareholders and plaintiffs can all lead to massive combined expenses that pale in comparison to effective prevention measures.
Third party consultants can provide objective assessments through robust quality system auditing to evaluate the key areas that come under regulatory scrutiny in areas such as GMP, GCP, GLP, Vendor/Supplier Management, Pharmacovigilance, and Data Integrity. These measures, when conducted routinely by unbiased outside experts, can be invaluable in preventing Quality System issues from developing into system-wide problems that can have enormous implications, both financially and otherwise.
3. Circumvent the Practical Challenges of Hiring From a Small Talent Pool
For most small or medium-sized companies, hiring high-salary internal regulatory compliance staff is simply unfeasible from a business perspective. Even for large firms, finding the top talent to fill these positions can be incredibly challenging. The relatively small pool of QA/RA talent creates intense competition for skilled personnel.
With the regulatory environment becoming increasingly globalized, it can be difficult for in-house regulatory departments to keep up with various regulatory requirements and changes. Third party experts can achieve harmony between disparate sets of requirements by conducting integrated regulatory assessments against national requirements from multiple jurisdictions.
4. Bring Industry Best Practices and Standards to Your Processes, Procedures, Systems
Third party consultants encounter a variety of challenges working in the field, and thus, develop a variety of solutions to address them. This gives them a very unique perspective into what works best when addressing a certain problem or preparing for a new development.
In general, most companies like to know what other companies are doing to handle similar issues. While consultants are obviously bound by contract not to reveal specifics, they're expected use their experience when developing best practices and standards to bring to each organization they work while also adding the scale and bandwidth needed to augment internal teams.
Consider the Costs
For many companies, seeking outside help from third party experts can provide overall greater value compared to doing all regulatory work internally. While a per-hour billing rates may initially appear high, the total financial picture can be one of cost savings when consultants are able to provide an ROI on overall efficiency versus the alternative.
• Effective consultants are valued for their ability to complete work quickly and without rework. This factor on its own is often enough to realize cost savings. Consultants who have conducted the same work many times and aren't affected by the distractions of daily tasks that internal personnel are, can often perform tasks far faster. Of course, consultants can only perform fast, effective work when the goals of the project are well-defined and organized ahead of time. This, in addition to ensuring a consultant is hired for their expertise rather than their billing rate are the two major factors that maximize efficiency while getting achieving the goals of a project.
• Companies can lower overall costs by carefully choosing the types of projects and process that they outsource. While just about any situation can warrant the added assistance of a consultant, consider those that require a high degree of specialization and/or those that are conducted on a periodic or project-based frequency.
As FDA-regulated manufacturers continue to compete for top talent in a globalized market while navigating a more complex regulatory environment, regulatory compliance and quality assurance consultants will continue to offer valuable pathways for planning and completing projects quickly, reliably, and cost-effectively.
Contact us today to learn how we can utilize our proprietary talent selection process of former FDA & industry professionals to provide world-class GxP auditing, remediation support, staff augmentation, regulatory affairs, and expert witness services.