Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a business is following official rules or laws regarding the safety and efficacy of products. Regulatory affairs professionals supervise the developing, testing,...
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Regulatory Strategy Development for Life Sciences: Best Practices
Regulatory Affairs and Winning Regulatory Strategy Regulatory strategy development is critical for life sciences companies seeking to bring new drugs, medical devices, and other products to market. Developing an effective regulatory strategy can help companies...
Benefit- Risk Assessment for Regulatory process
Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics, and medical devices, before it is approved for use by regulatory agencies such as the Food and Drug Administration...
Navigating Regulatory Inspections: Top 5 Remediation Best Practices
Regulatory compliance is essential in all industries, but it is easier said than done. Regulatory agencies strictly monitor organizations to ensure they adhere to the applicable rules and regulations. In doing so, they conduct regular inspections, and companies can...
Annual Submissions for US in regulatory processes
Annual submissions are critical in regulatorysubmission processes to maintain a product’s quality, safety, and efficacy over its duration in the market. These submissions are part of post-marketing activities for the product and are an essential part of the product’s...
Difference Between CTD and eCTD Submission Formats
What is an eCTD submission? The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator, such as the USFDA or EMA. The Common Technical Document describes the organization of...
Fulfilling Requests During an Inspection
In this blog article series on regulatory affairs inspections, we discussed the importance of making a good impression when the inspector or investigator arrives and how to do that. To prepare for the inspection – which can happen anytime – we talked about putting...
Preparing for an inspection: Building an Inspection Team
Site inspections regularly check and verify your organization's regulatory compliance, safety standards, and more. The FDA, EHS, and the EPA may do inspections and audits virtually or in the field. The FDA tries to inspect each licensed firm every two years or less....