Insourcing PV and RA: A sensible choice or a hidden expense?
Thinking of insourcing your PV and RA activities? Make sure the numbers add up.
For small and mid-sized pharmaceutical companies, taking pharmacovigilance (PV) and regulatory affairs (RA) in-house may seem like the right move. It promises more control, greater ownership and the potential for cost savings.
But many well-intentioned companies discover that the reality is more demanding than expected – and significantly more expensive.
This article outlines six overlooked reasons why full insourcing rarely supports long-term cost control, quality, or compliance, and why outsourcing to a trusted partner may, in fact, be the most responsible path forward.
1. Underestimating the complexity
There are benefits to building and running your own PV system, but it’s no small undertaking. It requires more than a set of SOPs and good intentions. True compliance demands ongoing documentation, monitoring, and capacity to respond to change. Unless you have a large, mature portfolio, it’s unlikely to be cost-effective.
Why it costs you: If you underestimate the workload or regulatory requirements, you either exceed your budget or face compliance gaps, both of which carry a price tag.
2. Outdated understanding of regulatory requirements
Regulatory standards have become more stringent and nuanced in recent years. Practices that were once acceptable may now delay or derail your authorisation process, especially in new markets.
Why it costs you: Delays, rejections, or additional review rounds due to outdated or incorrect processes can significantly increase time-to-market and resource use.
3. Applying GMP logic to GVP tasks
The mindset and methods used in Good Manufacturing Practice (GMP) cannot be applied directly to Good Pharmacovigilance Practice (GVP). Where GMP is generally prescriptive and detailed, the GVP guidelines leave more room for interpretation – and as a result, holds a greater potential for misinterpretation or even under-interpretation.
Why it costs you: A misaligned approach may result in misunderstandings, slower responses, and missed obligations, potentially triggering inspection findings.
4. Lacking internal skills
For small and mid-sized companies, recruiting and retaining experienced PV and RA professionals can be challenging. Tasks often fall to staff without specialised knowledge or to overburdened employees.
Why it costs you: Without a dedicated expert to keep the system compliant and current, mistakes go unnoticed until they become expensive to fix.
5. Overlooking the cost of continuous training
Your QPPV and other safety personnel must complete iterative annual and specific ad hoc training to maintain compliance. Additionally, at least one staff member must be certified to submit ICSRs and update EU product databases. If they leave, you must reinvest in training and certification. And because PV is a constantly evolving field, your team must continuously stay informed about legislative changes and regulatory expectations.
Why it costs you: Staying compliant requires time and budget for training, certification, and knowledge maintenance.
6. Leaving gaps in the 24/7 QPPV coverage
A QPPV is legally required for all EU/EEA marketing authorisation holders. Your QPPV must be experienced, and if not medically trained, you must ensure access to someone who is. Should your in-house QPPV leave, a replacement must be appointed and registered without delay. You’ll also need to secure appropriate back-up during holidays or other absences to stay compliant.
Why it costs you: An urgent need for interim cover can be both disruptive and expensive, and gaps in QPPV coverage can quickly lead to non-compliance and may delay your ability to act in critical situations.
Outsourcing is not a shortcut – it's a strategic safeguard
Sustainable governance in pharma means knowing when to build and when to partner. Beyond internal efficiency, PV and RA activities are a cornerstone of public trust in pharmaceuticals. For many SMEs, outsourcing PV and RA is not only the more affordable solution in the long run; it’s the responsible choice that protects patients, reputation and market access.