Gene Therapy Applications, Regulations & Guidance
The applications of gene therapy represent a revolutionary advancement in medicine, providing hope for curing diseases instead of relying on […]
Government Schemes For Medical Devices In India
India holds the 4Th largest medical devices industry in India with a huge capital. India has great skills in the
External Drivers For Regulatory Outsourcing
As markets are maturing, health authorities around the world are adapting to growing safety concerns and end users wellbeing. As
Digital Therapeutics: Combining Technology for Better Health Outcomes
Digital therapeutics (DTx) are evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder
Importance of Design History File (DHF) in Medical Device Development
The Design History File (DHF) is a crucial component in the development and manufacturing of medical devices. It serves as
Named Patient Program in India (CDSCO)
The Named Patient Program (NPP) approval process in India is designed to provide patients with access to investigational drugs that
CDSCO Medical Device Approval Cost & Fee Structure
Central Drug Standard Control Organization (CDSCO) is the regulatory authority that regulates Medical Devices in India. It is important to
Biologics and Biosimilars Regulations and Registration in South Korea
The Korean pharmaceutical market is estimated to be worth $24.3 billion in 2019, and between 2015 and 2019, it grew
CDSCO Simplifies Subsequent Importer Process for Medical Devices & IVDs
India’s regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has published an important update to streamline subsequent importer applications