Inspection Readiness

FDA to Begin Unannounced Inspections of Non-U.S. Manufacturing Facilities

Beginning August 2025, FDA inspections at non-U.S. manufacturing sites will take place without advance notice. This shift eliminates prior warning and signals a new standard for global regulatory oversight—one that demands continuous readiness.

With deep FDA expertise and regulatory professionals positioned around the world, ProPharma helps pharmaceutical, biotechnology, and medical device companies build and sustain inspection readiness—before the FDA arrives.

FDA to Begin Unannounced Inspections of Non-U.S. Manufacturing Facilities

Beginning August 2025, FDA inspections at non-U.S. manufacturing sites will take place without advance notice. This shift eliminates prior warning and signals a new standard for global regulatory oversight—one that demands continuous readiness.

With deep FDA expertise and regulatory professionals positioned around the world, ProPharma helps pharmaceutical, biotechnology, and medical device companies build and sustain inspection readiness—before the FDA arrives.

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.

inspection-readiness-workflow-illustration

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.

Inspection Readiness Experts

Unannounced inspections are coming. Preparation can't wait.

With global regulatory and quality expertise and a history of guiding clients through successful FDA inspections, ProPharma helps ensure your operations are always inspection ready—no matter when the FDA arrives.

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.

Group of business professionals working at a conference table with laptops and clipboards
Group of medical professionals smiling in a common area

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.
Healthcare provider looking into medical device

To date, we have had a 100% success rate on PAI Readiness projects for our clients

News & Insights

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ProPharma Receives 2024 CPHI Regulatory and Compliance Award

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News & Insights

FDA Launches Crackdown on Deceptive Drug Advertising

September 10, 2025

FDA Launches Crackdown on Deceptive Drug Advertising

FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.

Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Companies: A Tale of Two Paths

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Creating an Effective Global Audit Strategy for Medical Device and Diagnostic Co...

Discover two distinct paths for creating a global audit strategy in medical device companies, focusing on harmonization and compliance efficiency ahead of FDA's 2026 QMSR changes.

Transparency Requirements and the Requirement for Document Redaction

September 9, 2025

Transparency Requirements and the Requirement for Document Redaction

Navigate the EU CTR's updated transparency and redaction requirements with confidence. Learn what documents need redacting and how you can help protect sensitive data.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

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...

ProPharma Recognized for AI Excellence at ECCCSA

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.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

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.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

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.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Guide Your Roadmap to European Drug Approval: The Complete Solution - ProPharma

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Your Roadmap to European Drug Approval: The Complete Solution

Discover how ProPharma simplifies the complex journey to European drug approval by acting as a full-service Marketing Authorization Holder partner. From crafting regulatory strategies and...

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Agility Meets Expertise: The ProPharma FSP Approach

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From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

Previous Resource Arrow Next Resource Arrow
AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

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The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

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In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

Previous Webinar Arrow Next Webinar Arrow