Pre-Approval Inspection (PAI) Readiness is Easy, Isn't It?

Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with the reality of limited resources. For many companies, regardless of size and tenure, the culmination of fund raising, planning, and execution has led you to this – the need for a solid filing and a successful inspection. With funds running low, achieving approval and passing an inspection are essential to moving forward. There's a lot to consider, from key decisions to implementation, and the work ahead is substantial, especially if you are taking Inspection Readiness into account. Some examples include: 

Inspection processes and procedures
Request tracking and response documentation
Facility walk-throughs
Identifying the team that will coordinate the inspection
Identifying and preparing SMEs
Storyboarding
Opening presentations

The tasks mentioned here, well, they are just the tip of the iceberg when it comes to PAI readiness. Additionally, all of these tasks—and more—must be completed concurrently with your regular duties and…AND while you are working on a regulatory filing.

Even the largest, most experienced companies with vast resources still face challenges in getting it right. (Just take a look at the latest pharma news.)

There is good news. ProPharma is prepared to successfully guide you through this phase. Our team of SMEs not only have a demonstrated roadmap, but we have the experience to execute. We have a 100% success rate with firms that follow our model.

Why should you partner with ProPharma for PAI Readiness?

1. Filing Activities

Filing activities are extremely important and time-consuming. It goes without saying: without a filing, you will not have a PAI.

Whether or not you engage third-party assistance for the filing or its publication, a substantial portion of the responsibility falls on the sponsor organization and its critical vendors. Whether your organization is writing sections of the filing directly or is tasked with compiling and providing the necessary documents, reports, and data—as well as reviewing and approving the sections being written—these activities are both essential and time-intensive.

Did you know ProPharma offers expertise in Regulatory Sciences as part of its services?

2. Remediation Tasks

Without a successful PAI, your filing will not be approved.

A successful PAI requires preparation (logistics), the remediation of known risks, and execution.

With all of the planning your organization has done, you have likely hired a trusted firm, such as ProPharma, to conduct a Readiness Evaluation for your organization and for your critical vendors. At first glance, this may seem straightforward. Getting the help you need, with an outside perspective of your systems, facility, QMS and those of your critical vendors is essential and a load off your organization. Plenty of time to put the fixes in place (the remediations or optimizations), right? Perhaps—but only if this exercise was completed well in advance, ideally a year or more before your filing timeline.

Such an evaluation (also called a gap assessment or an audit) will help identify missing processes, procedures, systems, etc. or those that require some fine-tuning. But now, based on the findings of the evaluation, the real work begins when remediations and/or optimizations need to be put in place. It's important not to underestimate the time required. Don't be fooled, this takes time. From documenting and approving the Change Controls or CAPAs for the changes, the execution of the remediations, and the verification of their effectiveness – this takes significant effort.

The good news is you can lean on a trusted partner yet again. Whether it is the project management of remediation tasks to completion or a combination of staff augmentation (remediation task completion) and project management (tracking of tasks completion), a trusted partner, such as ProPharma, will significantly enhance your chances of success and add robustness to your timeline. Plus, with ProPharma having the experience and a reproducible, trusted process for successful inspections, it takes the guess work out of PAIs.

3. Daily Tasks (i.e. your everyday, full-time job)

While all of the above is occurring (filing, remediation, logistics, etc.), at the same time, you, your team, and your organization have ongoing responsibilities. Your staff is fully engaged in the daily, weekly, and monthly tasks required to run a successful life sciences organization. ProPharma can assist by providing experienced and knowledgeable resources for PAI planning, management, and execution, ensuring a successful inspection while minimizing disruption to daily operations.

PAI Readiness

PAI Readiness is a complex undertaking. With the extensive list of tasks mentioned earlier in this blog, along with the other necessary activities related to regulatory filing and Inspection Readiness, ProPharma is here to help. Let us handle the heavy lifting of PAI Readiness and ensure you are prepared for success.

With all the effort your organization has invested in the filing and the work leading up to it, can you afford to face PAI without the right support? Reach out to ProPharma for all your PAI Readiness needs.