US FDA Pharmacovigilance Requirements For Drugs in the USA
Pharmacovigilance is a cornerstone of drug regulation in the USA, playing a crucial role in ensuring the safety and efficacy […]
Case Study: Artixio’s Successful Registration of a Surgical Device with Taiwan FDA
This case study demonstrates Artixio’s Successful Registration of a Surgical Device in Taiwan with FDA. Client: A leading global surgical
Competitive Intelligence for a Global Anti-Depressant Drug Manufacturer
Artixio’s competitive intelligence experts are seasoned in developing comprehensive strategy across therapeutic areas, treatment modalities, and product types in global
Case Study: Streamlined India Registration and Market Entry for Europe Gel-Based Nail Polish Brand
Client: A prominent Europe-based Gel-Based Nail Polish brand with aggressive global market expansion plans. Problem Statement: The client faced the
Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate, Medical
What Is a Marketing Authorization Holder (MAH)?
A Marketing Authorization Holder (MAH) is an entity—whether an individual, company, or non-profit organization—that holds the regulatory approval to distribute,
DAV Introduces New Drug Registration Process in Vietnam
The regulation of drugs in Vietnam is the responsibility of the Drug Administration of Vietnam (DAV). The DAV is a
New Drugs, Generics and Biosimilars Registration in Singapore: Whitepaper on HSA Regulations
Singapore stands as a beacon of regulatory excellence in the pharmaceutical industry, offering a robust framework that ensures the safety,
Case Study: ASEAN Regulatory & Market Access Strategy for Japanese Pharmaceutical Manufacturer
Artixio, a leading consulting provider in the regulatory and commercial landscape, assisted a Japanese pharmaceutical company in expanding its footprint