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Introduction to Regulatory Affairs & Explanation of terms related to Regulatory Affairs

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Introduction to Regulatory Affairs What is Regulatory Affairs? Regulatory Affairs is a profession within regulated industries namely-pharmaceuticals, medical devices, energy and banking . It has specific meaning within healthcare industries namely- pharmaceuticals, medical devices, biologics and functional foods. (In this blog I am going to deal about Regulatory Affairs related to pharmaceuticals meant for human use). Regulatory Affairs in the pharma industry may be defined as " The interface between the pharmaceutical company and the regulatory agencies across the world. "   In the above presentation, I am conveying the fact that -among all the departments of a pharma company Regulatory Affairs Department acts as the interface between the pharmaceutical company and the regulatory agencies across the world. Regulatory agency in the present context may be defined as " The competent government agency which is responsible for ensuring that medici
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  What is an ANDA? The  ANDA pathway  is the process used to obtain approval to market a generic drug in the United States. Unlike an NDA Sponsor, an ANDA applicant is not required to demonstrate the safety and effectiveness of the drug for the conditions of use for which they are seeking approval of. Instead, the applicant must identify the reference listed drug (RLD) and relay that “FDA’s finding that the RLD relied upon by the ANDA applicant is safe and effective”. Sponsors must also include sufficient information “(1) to demonstrate that the proposed product is bioequivalent to the RLD5 and (2) to ensure the product’s identity, strength, quality, and purity”. Tentative Approval Meaning Tentative approval (also known as “TA”) is a notification granted by the FDA if an ANDA meets the substantive requirements for approval, but cannot obtain final approval for marketing due to unexpired patents or exclusivities. A grant of tentative approval does not mean the drug is approved, it
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GAP or Findings in Regulatory Compliance

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Gap Analysis for Regulatory Compliance Gap analysis is an effective tool to determine the deficiencies in implementation of any procedure or regulatory guidance. If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis. Gap analysis should be done for all SOPs, validation procedures and other activities to find out the possibilities of improvement. The room for improvement is identified by gap analysis. Therefore, make the checklists of the document you want to analyze and then check the actual working against the checklist. Gap analysis should also be done for regulatory guidelines like data integrity, risk assessment, good manufacturing practices, good laboratory practices, good documentation practices, good distribution practices etc to eliminate the possible non-compliances. Gap analysis may be carried out for specifi
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Artificial Intelligence in the Medical Robotics Industry – Current Applications

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AI applications for healthcare are becoming more common for white-collar automation and diagnostics . However, medical robotics is an area that may be marginally underdeveloped. This is likely because of regulations concerning automated surgery. In this article, I cover how AI software is finding its way into medical robotics now and how it might in the future with more investment and when the density of AI talent at medical robotics companies increases. Specifically, we explore: AI for Medical Robotics – What’s Possible, and What’s Being Used by healthcare clients right now. We found little to no case studies showing a health network or hospital’s success with AI-based medical robotics. The State of AI at Medical Robotics Vendors – the AI talent at medical robotics companies and a discussion of how to vet a vendor on whether or not its software is truly leveraging AI We begin our exploration of AI applications for medical robotics with an overview of the po
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