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benfits of ISO 27001 Certification

Why is an ISO 27001 Certification Important For an Organization?

Blogs, Regulatory /

In a technology-driven era where businesses are increasingly incorporating advanced information and data management tools into their operations, the risk of facing cyber attacks and breaches is also increasing. Additionally, businesses face non-compliance in regulatory and legal requirements when handing information security, and so the demand for transparent information security is on the rise- particularly […]

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RIMS Tools in Asia Market

Role of Regulatory Information Management Systems -RIMS Tools in Asia Market

Blogs, Regulatory /

Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry. Now, as more opportunity markets emerge bringing their own stringent regulations and changes in previous regulations, managing regulatory information is becoming increasingly complex which can delay market access for products. Furthermore, information is

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Regulatory Affairs in Pharmaceutical

Role of Regulatory Affairs in the Pharmaceutical Industry

Blogs, Regulatory /

The pharmaceutical industry is highly regulated using legislations and regulations that bring together administrative, technical, and legal information about a medicinal product. These can be a combination of guidelines, procedures, policies, etc., that pharmaceutical organizations must adhere to, or follow, to get market approval for their products. This way, governments and their relative health authorities

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Pharmacovigilance

India’s New Drugs, Medical Devices and Cosmetics Bill 2022

Blogs, Medical Device, Regulatory /

Drug laws & regulations in India have roots that are almost 80 years old. India still follows drug laws that were framed in pre-independence time through Drugs & Cosmetics Act – 1940 and Rules 1945. The laws & rules have frequently been amended to address the challenges posed by Indian pharma Industry. However, the basic

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Quality Management Maturity Program

Quality Management Maturity Program by the CDER of the U.S. FDA

Blogs, Pharmacovigilance /

The pharmaceutical industry is one that is constantly growing and simultaneously facing challenges in Quality Management Maturity Program in US FDA. The onset of the pandemic has brought new obstacles that require immediate attention and innovative solutions. Quality assurance (QA) is a routine measure that ultimately ensures patient safety by making sure all pharmaceutical products

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Regulatory Compliance Outsourcing solutions provider in pharmaceutical industry

Regulatory Compliance Outsourcing Solutions

Blogs, Regulatory /

In an era of technological advancement, and easy access to such disruptors, pharmaceutical organizations are increasingly looking to outsource their solutions to enhance efficiency and reduce cost. Inevitably, there are many benefits to Regulatory Compliance Outsourcing in the pharmaceutical industry that include operational control, faster time-to-market, increased flexibility & revenue, quality production and ultimately lead

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QPPV Training in pharmacovigilance

Why QPPV Training is the Key to Pharmacovigilance Success?

Blogs, Pharmacovigilance /

Drug safety is all about the right patient receiving the right drug at the right time for an improved outcome for each patient. To achieve this, a Qualified Person Responsible for Pharmacovigilance (QPPV) Training is held responsible for the pharmacovigilance services management of the quality of a pharmaceutical company. This could be a person who

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