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Quality Lifecycle Management

Quality Lifecycle Management: Improve Quality & Compliance

In today’s competitive business landscape, ensuring high-quality products and services is crucial for the success of any organization. To achieve this, businesses are turning to…

Quality by Design (QbD): A systematic approach to drug development

The Quality by Design (QbD) approach is gaining more significance during the drug development process. This comprehensive and proactive approach aims to ensure quality is…

Quality Auditing: A Deep Dive into Ensuring Excellence

Quality is paramount in any business. It signifies trustworthiness, reliability, and consistency. Without a defined measure of quality, products or services can become inconsistent, which…

Medical Devices: The categories and the regulatory landscape

Medical devices encompass a wide range of products designed to diagnose, monitor, treat, or alleviate medical conditions. The regulatory landscape for medical devices varies globally…
ISO 13485 Quality Management System for Medical Devices

ISO 13485: A Quality Management System for Medical Devices

ISO 13485 in Medical Device An ISO 13485 consultant is a qualified professional who can help medical device manufacturers implement and maintain an ISO 13485…
International Regulatory Framework IRF

International Regulatory Framework (IRF): Navigating Global Standards

What is International Regulatory Framework (IRF)? The IRF or International Recognition Framework is a new initiative that aims to streamline the regulatory approval process for…

Internal Auditing: Significance and the Regulatory Expectations

Internal auditing is a crucial component of the pharmaceutical industry that is responsible for ensuring compliance with regulations, maintaining product quality, and managing risks associated…
GxP Regulatory Best Practices

Implementing GxP Regulatory Best Practices

In the heavily regulated industries like pharmaceuticals, biotechnology, medical devices, and food production, adherence to Good Practice (GxP) regulations is of utmost importance. These regulations…

HVAC Systems: Requirements and significance in the life sciences industry

The HVAC (Heating, Ventilation, and Air Conditioning) systems in the life sciences industry play a critical role in maintaining the necessary environmental conditions for various…

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