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Blogs

Regulatory Information

Regulatory Information Management Systems (RIMS)

Blogs, Regulatory / By

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

Role of Regulatory Affairs in the Pharmaceutical Industry

Blogs, Regulatory / By

The pharmaceutical industry is one that is highly regulated by means of 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 …

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Pharmacovigilance

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

Blogs, Medical Device, Regulatory / By

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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Drug Evaluation

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

Blogs, Pharmacovigilance / By

The pharmaceutical industry is one that is constantly growing and simultaneously facing challenges. 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 are of high-quality and compliant with regulatory and …

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Regulatory Compliance

Outsourcing regulatory compliance solutions

Blogs, Regulatory / By

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 outsourcing in the pharmaceutical industry that include operational control, faster time-to-market, increased flexibility & revenue, quality production and ultimately lead to increased …

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