eCTD Structure & Submission Process
The Electronic Common Technical Document (eCTD) is the standard electronic format used for many regulatory submissions involving drugs and biologics. […]
Virtual Reality (VR) and Augmented Reality (AR) in Pharma
Pharma companies have started using Virtual Reality (VR) and Augmented Reality (AR) in a few areas. Applications include training manufacturing
CDSCO Cosmetics Import Registration in India
Imported cosmetics need CDSCO registration before they can be imported and sold in India. The process is governed by the
FSSAI Regulations for Alcoholic Beverages in India
India regulates alcoholic beverages under the Food Safety and Standards (Alcoholic Beverages) Regulations, 2018. The framework has been amended several
Named Patient Program in India: CDSCO Rules, Form 12A & Form 12B
In India, some patients may need medicines that are not normally available in the country. Rule 36 of the Drugs
COFEPRIS Reliance Pathway in Mexico
Getting a medicine or medical device approved in a new country can involve repeating many of the same regulatory checks
Chile Cosmetics Regulations & Registration Requirements
In Chile, cosmetic products are regulated by the Instituto de Salud Pública de Chile (ISP). Within ISP, ANAMED manages the
What Is Company Core Data Sheet (CCDS)?
A Company Core Data Sheet (CCDS) is a central reference document used by pharmaceutical companies for product information and labeling.
Global Medical Device Statistics, Facts & Trends 2026
There are an estimated 2 million different kinds of medical devices on the world market, grouped into more than 7,000