How to find the best pharmaceutical regulatory consulting services


    Does the thought of an FDA audit, warning letter or recall make you nervous? The cost of non-compliance with current good manufacturing practice (cGMP) is higher than ever - making pharma compliance consulting more important than ever for businesses without internal expertise.

    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 of 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. Pharmaceutical regulatory 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 pharmaceutical compliance services for your organization.


    What does a pharmaceutical regulatory affairs consultant do?


    Regulatory affairs consultancy is often a necessary outsourced service for companies in the pharmaceutical industry.

    Pharmaceutical companies have a complex, contextual and potentially bewildering web of regulations and standards to maintain compliance with, from GMP to PIC/S and ICH considerations.

    Pharma compliance consulting is ultimately about guiding your organization towards a state of natural, repeatable compliance with the regulations that apply to you, and insulating your business from the risk of compliance slip-ups and lapses.

    Pharmaceutical regulatory consultants are typically drafted into pharmaceutical start-ups and scale-ups, since these organizations are often less mature in their quality and compliance approaches and have lower levels of internal expertise. However, pharmaceutical compliance consulting could be useful for businesses of any size - particularly to support new projects such as international expansion, or compliance with a new quality benchmark.


    How much does a regulatory consultant charge?


    Regulatory affairs consultancy costs naturally vary, according to the territory you operate in, the breadth and scope of your consultancy project, and the individual consultant themselves.

    Pharma compliance consulting often comes with a minimum retainer if charged by the hour. Alternatively, your consultant could charge by project.

    Aim for a daily cost of $1500 as an approximate rule of thumb, and budget accordingly.


    How to find the best pharmaceutical regulatory consulting services


    The best pharmaceutical regulatory consultant for your business is someone with extensive, relevant and recent experience. The top pharmaceutical regulatory consultants have relevant experience of the industry, knowledge of its regulatory frameworks, and proven experience working on similar projects.

    Regardless of whether you’re trying to develop a regulatory strategy, prepare for a drug license submission or respond to the FDA, working with a pharma compliance consulting expert who’s succeeded in similar situations can increase your chances of a favorable outcome.


    RELATED READING: Quality Management Consulting: How to Evaluate and Choose the Best Consultant



    Selecting pharmaceutical regulatory consultants


    Relevant pharma compliance consulting experience is crucial for this 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 pharmaceutical regulatory consultants gain relevant industry experience through years of pharma compliance consulting work, or through prior employment at industry bodies like the FDA or ISPE. Others come to pharma compliance 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, pharmaceutical quality assurance, drug labeling, or other sub-specialties.

    The pharmaceutical industry is among the most highly regulated sectors in the US. A qualified regulatory affairs consultancy expert must have specific knowledge of the pharmaceutical industry, and relevant experience consulting pharma companies with FDA compliance, warning letters, clinical 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


    Pharmaceutical 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 start-ups and scale-ups hire pharmaceutical 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 pharmaceutical compliance consulting 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.

    Pharmaceutical regulatory consultants who offer generic experience with ISO or FDA requirements may not have the depth of specific regulatory expertise needed to take your drug to market. Verify experience with similar drug products to ensure the consultant has succeeded on similar projects. Relevant experience matters most if your drug has unique regulatory requirements, such as controlled substances.

    Evaluate prospective pharmaceutical compliance services by looking into client testimonials and case studies or, better yet, by verifying client references.


    RELATED READING: 10 Considerations for Responding to an FDA 483 Letter



    Proven success with similar pharma 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 regulatory affairs consultancy 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.

    Learn More: 5 Notorious Compliance Issues in the Pharmaceutical Industry (and How to Avoid Them)


    Direct experience with software


    Modern regulatory compliance for pharma is much easier with modern digital tools. In virtually any case, you can benefit from hiring someone who is a specialist in pharmaceutical software tools such as eQMS software. A generalist who hasn’t worked directly with pharma software 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, pharmaceutical regulatory consultants with direct software knowledge can provide an extra competitive advantage. The following use cases are a few situations where software expertise really matters:

    • Implementing eQMS software for the first time or switching to a new pharmaceutical eQMS
    • 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 pharmaceutical compliance services. If you’re thinking about outsourcing your quality management or pharmaceutical compliance serviceswith a monthly retainer, ask your current QMS software vendor if they can recommend a regulatory affairs consultancy expert.


    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 quality management software for growing life science organizations, Qualio has worked with hundreds of early-stage pharma companies. It’s never too early to hire pharmaceutical regulatory consultants, especially if you’re overwhelmed by the idea of creating a regulatory strategy from scratch. We’re happy to recommend the best pharmaceutical regulatory consultants for your project. To learn more, click here to start a conversation.