Inspection Readiness is not an option – now, more than ever, it is urgent.
Our team of experts is equipped to guide you through every step of any inspection your firm is facing, with experience and expertise. The overview below outlines how ProPharma supports clients through every stage of the inspection readiness lifecycle.
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.
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 risk the time and resources you invested in development by ignoring the importance of Inspection Readiness for a new product?
- Can you risk having an existing product off the market for remediation activities following a For Cause Inspection?
- Can your patients?
ProPharma's expertise covers all aspects of Inspections. Inspection Readiness Evaluation, Project Management, your Inspection Program/Process, Logistics, and Training – are just some of the most important areas of Inspection Readiness. Our expertise can become your greatest asset. We are eager to become your partner in navigating this critical process.
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.
BIMO Readiness
BIMO inspection readiness is essential for sponsors to ensure compliance with FDA regulations, protect data integrity, and uphold patient safety standards. By preparing thoroughly, sponsors:
- Ensure compliance with FDA regulations.
- Protect data integrity.
- Uphold patient safety standards.
- Help avoid costly delays.
- Prevent potential compliance issues.
- Facilitate smoother FDA inspections.
News & Insights
July 31, 2025
Pros and Cons of Working with a CRO
Explore the pros and cons of working with a Contract Research Organization (CRO) and how ProPharma sets a new standard in clinical development success.
July 28, 2025
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Learn about PADER, a crucial pharmacovigilance requirement for U.S. drug safety monitoring, and how it differs from PSUR in ensuring compliance and patient safety. Summarizing the main point of the...
July 25, 2025
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...
Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).
.png?width=320&height=185&name=Obesity%20%E2%80%93%20Accelerated%20Timelines%20(1).png)
.png?width=320&height=185&name=labeling-webinar-thumbnail%20(1).png)
News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
