<span class="archive__title-prefix>Posts Categorized:</span> Blog

When it comes to drug approvals and post-approval changes in Asia-Pacific (APAC) markets, are you aware of the various requirements? In this article, originally published on October 15, 2020, Redica Systems Senior GMP Quality Expert Jerry Chapman examines these requirements and includes a small case study involving a post-approval change in South Korea. AbbVie Global […]

Does successful completion of an FDA pre-approval inspection (PAI) influence the timing of a subsequent surveillance inspection? And should it? [Related: For more on PAIs, view our recent webinar that includes insights from inspection trends presented by Redica Systems CEO Michael de la Torre.] This topic was addressed by FDA representatives at the 2022 PDA/FDA […]

If your company is navigating the drug product approval process in the Asia-Pacific (APAC) region, it is critical to understand the varying requirements, particularly within smaller markets. This article by Redica Systems Senior GMP Quality Expert Jerry Chapman, originally published on October 8, 2020, contains information about the drug approval processes for specific markets in […]

What are the regulatory surveillance signals I need to be most concerned about? And how can my team find structured insights from multiple sources? Download the Redica Systems webinar, “Top 10 Regulatory Surveillance Signals of Summer 2022,” presented on October 13 by Redica Systems CEO Michael de la Torre and Head of Regulatory Intelligence Operations […]

Who decides how inspection results are interpreted and who decides how an inspection becomes classified as Official Action Indicated (OAI) rather than Voluntary Action Indicated (VAI) or No Action Indicated (NAI)? And how much influence does the investigator who performed the inspection have on that decision? This topic was addressed by FDA representatives at the […]

The following article by Redica Systems Senior GMP Quality Expert Jerry Chapman contains insights for companies intending to market new drugs in four Latin American countries: Mexico, Argentina, Colombia, and Peru. It was originally published on November 14, 2020. At the FDA/Xavier PharmaLink conference held virtually in March 2020, Merck CMC Director and Senior Scientist Tatiana Gaban—who has […]

Creating a Workplace with the Right Quality Mindset The following is a guest article from quality executive Anders Vinther, PhD. How do you create and maintain a quality culture in your organization, one that “produces good quality?” I was asked to speak about that at a conference because that is what I have done for […]

  Is your company trying to get new drugs approved in Brazil? In this article, originally published on Sept. 24, 2020, Redica Systems Senior GMP Quality Expert Jerry Chapman provides insights into the country’s CMC requirements and what they mean for getting drugs approved in this market. Brazil—the largest country in South America with the […]

Have you wondered why, after an FDA inspection that is classified No Action Indicated (NAI) or Voluntary Action Indicated (VAI), the inspected firm is given a copy of the Establishment Inspection Report (EIR) relatively quickly, but when an Official Action Indicated (OAI) classification is assigned, the EIR is not sent? During a Q&A session at […]

During a Q&A session at the 2022 PDA/FDA Joint Regulatory Conference in mid-September in Washington, D.C., CDER Office of Compliance Director Donald Ashley and Office Director of the Office of Manufacturing Quality Francis Godwin provided insight regarding compliance issues in pharma companies. The following questions from attendees were among those addressed: What factors are considered […]