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DDReg Pharma

Regulatory

Regulatory Affairs

Role of Regulatory Affairs in the Pharmaceutical Industry

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

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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Regulatory Compliance

Outsourcing regulatory compliance solutions

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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