Does the thought of an FDA audit, warning, or recall make you nervous? The cost of non-compliance with current good manufacturing practices (cGMP) is higher than ever.
The FDA continues to take action against pharmaceutical companies that fail to comply with cGMP and stringent drug quality standards. Recently, Mylan Pharmaceuticals initiated a massive recall of an anti-anxiety drug due to the “potential presence of a foreign substance.” At the time of the recall, no adverse patient events had been reported.
The average cost of an FDA recall is $10 million in direct expenses, which doesn’t include reputational damage or loss of patient trust. The most expensive drug recall to date, which involved 31 million bottles of tainted Tylenol, carried a price tag over $100 million.
A pharmaceutical regulatory consulting service can help you navigate regulatory audits or respond to actions to get resolution as painlessly as possible. Consultants can help you manage the costs of compliance, and avoid the sky-high losses associated with a drug recall. Here's how to find the best one for your organization.
Finding the Best Pharmaceutical Regulatory Consulting Services
The best pharmaceutical regulatory consultant is someone with extensive relevant, recent experience. The top consultants have relevant experience within the pharmaceutical industry, knowledge of the right regulatory frameworks, and proven experience working on similar projects. Regardless of whether you’re trying to develop a regulatory strategy, prepare for a submission or respond to the FDA, working with a consultant who’s succeeded in similar situations can increase your chances of a favorable outcome.
Relevant, Recent Industry Experience
Relevant experience is crucial in the pharma vertical. Avoid hiring someone with blanket regulatory experience or a generic healthcare consultant. You need someone experienced with FDA regulations for the pharmaceutical industry, since navigating the regulatory framework for drug manufacturers is highly complex.
Some of the most qualified consultants gain relevant industry experience through years of consulting work or prior employment at the FDA. Others come to consulting after successful industry careers in drug safety, pharmaceutical science, FDA regulatory positions at major pharma companies, or clinical trial work.
Relevant industry experience may include a vertical specialty in topics which align with your project. Some pharma regulatory consultants have particular expertise in FDA regulations and law, regulatory affairs, clinical trials, drug labeling, or other sub-specialties.
The pharmaceutical industry is among the most highly regulated sectors in the US. A qualified consultant must have specific knowledge of the pharmaceutical industry, and relevant experience consulting pharma companies with FDA compliance, warnings, trials, or other areas related to your use case.
Regulatory specialist Allison Koniyama says she's often asked about her recent experience working on similar projects. Koniyama says she advises these prospective clients to start asking, “how many of these projects have you worked on recently?” FDA regulations change quickly, and the best pharma regulatory consultant needs to be on top of the latest changes.
Knowledge of Regulatory Requirements and Certification Frameworks
Regulatory consultants often step into midsized or enterprise pharma companies to assist in a “fix it” role. One of the best-known examples of emergency regulatory consulting can occur when a company receives a 483 letter from the FDA or fails an ISO audit. A consultant can step in to quickly address a laundry list of pharmaceutical compliance issues before they spiral into costlier problems. However, this definitely isn’t the only use case. Pharma startups and scale-ups hire regulatory consultants to create a regulatory strategy, and in other cases, fully outsource their regulatory affairs to a consultant to create a solid groundwork.
Regardless of why you’re engaging with a regulatory specialist, you need to make one thing clear. Your consultant or firm needs to have relevant experience with your specific regulatory pathway and certification frameworks. Even the most experienced FDA consultant in your state might not be able to deliver on a project if their background is primarily in medical devices or ISO 13485.
A consultant who claims generic experience with ISO and/or FDA cGMP may not have the depth of specific regulatory expertise needed to take your drug to market. Verify experience with similar drug products to ensure a consultant has succeeded on similar projects. Relevant experience matters most if your drug has unique regulatory requirements, such as controlled substances. Substantiate a prospective consultant’s experience by looking into client testimonials and case studies, or better yet, verifying client references.
Related Reading: 10 Considerations for Responding to an FDA 483 Letter
Proven Success with Similar Clients or Workplace Projects
The right type of pharmaceutical regulatory consulting service should have direct experience working with clients or projects that involved a similar type of drug. Consider a consultant’s experience working with companies that are a similar size or growth stage to your own, especially if you’re a small startup or scale-up. A prospective consultant may struggle to find a cultural fit if they’re inexperienced working with similar clients.
Ideally, your consulting service should have experience with similar therapeutic products. This can be particularly valuable if your product is facing a more challenging pathway based on risk or classification. Seek out someone with success on similar submissions, and someone who’s been actively consulting in the pharma space recently.
Direct Experience with Your QMS Software
Regulatory compliance for pharma requires a quality management system. In virtually any case, you can benefit from hiring someone who is a specialist with your current QMS software. A generalist who hasn’t worked directly with your QMS platform can delay your time-to-value if they need to learn the specific software’s best practices or receive training from your vendor.
In some instances, a specialist with direct QMS software knowledge can provide an extra competitive advantage. The following use cases are a few situations where software expertise really matters:
- Implementing QMS software for the first time or switching to a new pharmaceutical QMS
- Adding new capabilities to an existing QMS
- GCP & GMP audits
- Software validation
- Regulatory remediation services after a warning letter
- ISO certification and compliance
In addition, an expert consultant who specializes in your software can be a particularly valuable partner if you’re considering long-term support services. If you’re thinking about outsourcing your quality management or regulatory support services with a monthly retainer, ask your current QMS software vendor if they can recommend a consultancy.
Finding the Best Pharmaceutical Regulatory Consulting Service
“The best” pharma regulatory consultant is set apart by the depth of their experience. However, don’t forget the importance of finding a consultant whose experience fits your company’s needs. Experience can be measured in education and years of industry experience, but it’s also a measure of relevant project works. A prospective consultant needs to be comfortable working within your company’s culture, especially if you’re an early-stage startup or scale-up.
As a leading provider of life sciences quality management software for organizations with 5-500 employees, Qualio has worked with hundreds of early-stage pharma companies. It’s never too early to hire a regulatory consultant, especially if you’re overwhelmed by the idea of creating a regulatory strategy from scratch. We’re happy to recommend the best consultants for your project. To learn more, click here to start a conversation.