Regulatory services in Australia play a vital role in ensuring the safety, quality, and efficacy of therapeutic goods, including medicines, medical devices, and biologicals. The Therapeutic Goods Administration (TGA) is...... Read More
Author: DDRegpharma
Regulatory affairs certification is a valuable credential for professionals working in the healthcare, pharmaceutical, biotechnology, and medical device industries. It demonstrates expertise in navigating complex regulatory requirements, ensuring that products...... Read More
Australia’s drug regulatory landscape is evolving to support faster, more efficient approval of innovative medicines. The Therapeutic Goods Administration (TGA) has introduced streamlined pathways such as Priority Review and Provisional...... Read More
Pharmacovigilance in Saudi Arabia plays a crucial role in ensuring the safety and effectiveness of medicines used within the country. Overseen by the Saudi Food and Drug Authority (SFDA), the...... Read More
Regulatory submissions often look like a storm of guidelines, timelines, and checklists waiting to spiral out of control. That’s where DDReg steps in, the hero that brings order to the...... Read More
With the increasing complexity of healthcare products, pharmacovigilance requirements are evolving to include not only drugs but also medical devices and combination products. Globally, regulatory authorities are placing greater emphasis...... Read More
South Africa’s Health Products Regulatory Authority (SAHPRA) plays a critical role in overseeing the registration and regulation of complementary and traditional health products. These include herbal medicines, homeopathic remedies, and...... Read More
Post-market evidence generation is essential for ensuring the continued safety, effectiveness, and value of health products. By integrating pharmacovigilance (PV) data with health technology assessment (HTA) requirements, stakeholders can support...... Read More
Generative AI refers to algorithms that can create new data, designs, or models by learning patterns from existing datasets. In life sciences, it has the potential to revolutionize drug discovery,...... Read More
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory body responsible for ensuring the safety and compliance of cosmetics sold in Mexico. Global cosmetic brands looking...... Read More