FDA Pre-Approval & EMA Pre-Authorization Inspection Consulting Services

Commercialization is on the Horizon: Don't Let Inspection Readiness Delay Your Approval

The Pre-Approval or Pre-Authorization Inspection (PAI) may be all that stands between your company and its approval to market a new product. With the long awaited and much anticipated approval right around the corner, now is not the time to risk the possibility of time-consuming and costly Regulatory Agency observations. Who better to help you prepare for this final milestone than a diverse range of technical and regulatory compliance subject matter experts who have successfully undergone numerous PAI inspections themselves?

ProPharma Group’s customized, global PAI consulting services’ primary goal is to assure compliance of the company’s, or applicable Contract Manufacturing Organization’s (CMO), activities with US FDA and EU EMA requirements, however the ProPharma Group difference means we take it one step further. We approach PAI projects as a way to collaborate with the audited firms and sponsors in order to develop a risk-based remediation plan. Not only are a number of our PAIs executed by or in conjunction with ex-FDA and EU agency auditors, but we also deliver detailed observations of the areas/systems reviewed. Most importantly, we provide recommendations, corrective actions, and resources needed to address the deficiency, mitigating compliance risk and helping to ensure a successful FDA and EMA PAI.

We offer PAI consulting services cross-regionally to ensure availability of all required knowledge for a successful world-wide route towards market approvals. In the USA, our services simulate a typical FDA Pre-Approval Inspection per the Compliance Program Guidance Manual (CPGM).  For EMA Pre-Authorization, ProPharma Group’s consulting services mirrors an inspection with focus on compliance against various guidance and Annex documents. Our global expertise and experience in FDA and EMA compliance allows us to align and coordinate resources to get the project completed within your budget and project schedule goals.