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...
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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...