Overcoming the challenges of registration of a generic drug in Singapore

A generic product must have the same qualitative and quantitative composition in active ingredients and be of the same pharmaceutical form as a currently registered product in Singapore and shown to be bioequivalent to Singapore Reference Product (SRP). A marketing authorization application for a generic product fall under the application category of GDA-1 and GDA-2 […]

22 Aug 2023 |
Pharmaceutical Consulting

Regulatory Affairs: What is it and What does it Entail?

Regulatory affairs management in the pharmaceutical industry is important to ensure compliance with regulatory guidelines.

14 Jun 2023 |
Regulatory Affairs

How A Regulatory Affairs Subscription Plan Can Benefit Your Company

As a global hub for pharmaceutical research, development, and manufacturing, Singapore prides itself on its stringent regulations that prioritise the safety, efficacy, and quality of pharmaceutical goods available within its borders. These strict guidelines help to safeguard public health by ensuring that residents have access to only the best and the safest products. However, this […]

05 Feb 2023 |
Regulatory Affairs Management

How to set up a Quality Management System for a SME in medical field

A Quality Management System is a set of guidelines and operating procedures to ensure that the company meets its objectives to provide quality and efficient product and services.

31 Mar 2022 |
Quality Management