Pre-Approval Inspection (PAI) Readiness

Ensure Your Product's Path to Market with Expert PAI Support

We ensure that every step towards Inspection Readiness is carefully calibrated to your needs. Our method is backed by tangible tools and training programs developed from the ground up, tailored not just to your product, but to your organization's unique scale and scope. This approach allows you to maintain focus on running your business, while we dedicate ourselves fully to your Inspection Readiness, making it our singular priority.

PAI Readiness

Pre-approval Inspections are one of the most critical inspections any Biologic, Pharmaceutical or Medical Device firm will undertake. Failure to meet FDA expectations can have a huge impact on organizations, including:

• Delays to product launch
• Thousands, if not millions of dollars, in remediation costs
• Lost market share
• Loss of a firm’s credibility

PAI readiness is critical, and ProPharma is an industry leader in providing PAI Readiness to our clients. To date, we have had a 100% success rate on our PAI Readiness projects.

Secure Your Regulatory Inspection Success

On average a new product takes approximately 10-15 years to develop, whether it is a biologic, a pharmaceutical product, a medical device, or a combination thereof. Can you really risk the time and resources you invested in development by ignoring the importance of Inspection Readiness? Can your patients?

ProPharma's expertise covers all aspects of Inspections. Inspection Readiness Evaluation, Project Management, Inspection Program development, and Training, are just some of the most important areas of Readiness. Our expertise can become your greatest asset. We are eager to become your partner in navigating this critical process.

ProPharma can Provide and Support Your PAI Needs

Inspection readiness, whether it be a PAI or other Regulatory Inspection, is both a mindset and a practice. ProPharma can help you get there using one or all of our full suite of Inspection Readiness offerings. From Inspection Readiness Evaluations through to supporting you onsite or remotely during your PAI, we are your partner. And as your partner, we are highly skilled, collaborative, and dynamic.

Pre-Approval Inspection Services

Project Management

Project Management is critical to the success of every project. No example is better than the importance of Project Management for PAI Readiness. Inspection Readiness has a multitude of simultaneous and associated activities. These activities include assessments and evaluations, remediation and optimization, logistics planning and execution, training, mock inspections, etc. And, of course, there is the ever present need to conduct “business as usual” concurrently. The everyday work does not stop while a firm is getting "Inspection Ready". The Project Manager will initiate, plan, and monitor all readiness activities with quality, budget, and timeline in mind.

Inspection Readiness Evaluation

Our industry experts will audit and evaluate all aspects of your organization that are vital to a filing and commercialization - Quality Management Systems (QMS), Development, Manufacturing, Laboratories etc. Additionally, we can provide similar evaluations of your CROs, CMOs, and Testing Laboratories. It is important to note that any organization listed in the filing is subject to inspection and should prepare.

ProPharma will produce a report outlining observation criticality and recommendations to aid in remediation and optimization efforts for your firm.

Personalized Training

ProPharma can provide and execute various trainings to ensure Inspection Readiness. The entire organization will be trained on why PAIs occur and what to expect. Additionally, SMEs require and benefit from training on proper interviewing skills and responses to Inspectors’ questions. And finally, the Inspection Management Team’s training on roles, responsibilities, and their deliverables to ensure a smooth inspection experience for all.

Remediation & Optimization

As an outcome of the Inspection Readiness Evaluation or other gap assessments, remediation or optimizations efforts with respect to policies, procedures, practices, documentation, facilities, etc. will likely be required. These activities can vary in size, criticality, or effort. Teaming with ProPharma for your firm’s remediation and optimization needs puts your firm closer to the finish line on your road to filing and Inspection Readiness. We have the experience and expertise to help guide you through the activities and ensure compliance and quality are maintained throughout.

Develop/Optimize an Inspection Program

ProPharma can create Standard Operating Procedures (SOPs) on how inspections are handled at your organization and/or vendor organization. We can implement request and response processes (paper-based or electronic). We can develop all of the tools necessary for a successful PAI. Alternatively, we can review your existing Inspection processes and optimize them as necessary.

Inspection Assistance

Our highly experienced team members can support you in many areas during an Inspection. We have the experience to help you ensure your site is prepared to handle Inspectors and the nuances that come with hosting an Inspection. It’s vital to have support systems and support personnel trained, prepared, and tested to avoid hiccups during the Inspection. ProPharma’s experience cannot be overstated in this area, we have been through 100s of Inspections, and this is exemplified by our 100% success rate on PAI Readiness projects.

Response Help

ProPharma is adept with Agency responses to observations, as well as Deviation and CAPA creation for remediation actions.

Storyboarding

The most experienced and prepared organizations can still have "difficult to explain" or complex scenarios. The process of storyboarding allows the organization to align talking points on the complicated scenario. ProPharma has tools, templates, and training that are extremely useful for such scenarios.

Mock Audit

ProPharma has helped many organizations plan and execute Mock Inspections with utilization of our former FDA investigators as well as our industry experts. Mock Inspections help ensure that the implementation, remediation, or optimization of processes has been a worthwhile effort as well as ensuring training on Inspection behavior has been successful.