Role of PRRC under EU MDR and IVDR
Compliance under EU MDR and IVDR is no longer managed in fragments. Instead, accountability has been concentrated into a clearly […]
Meeting EU Regulations: Role of the European Authorized Representative (EAR)
Placing a medical device on the EU market involves shared responsibility. For manufacturers outside the EU, part of that responsibility
Case Study: Nitrosamine Impurities Analysis – Artixio’s Strategic Staffing Solutions for a Generic Drug Manufacturer based in the USA
Artixio stands out in the regulatory staffing industry by offering a unique blend of Lifesciences expertise, flexibility, and a global
510(k) Registration with US FDA – Medical Device Registration in USA
Medical devices regulatory compliance is paramount to ensure patient safety and effective product performance. The 510(k) registration process, overseen by
Regulations for Pharmaceutical Registration in Hong Kong
Pharmaceutical market in Hong Kong has reached a significant size, estimated to be around $2.3 billion. This figure highlights the
EU MDR Labelling Requirements For Medical Devices
Labelling under EU MDR is no longer something manufacturers handle at the last stage. What goes on the label is
Digital (SEO) Strategies for a USA based Surgical Instruments Company
Summary Boosting Surgical Company’s digital presence, driving improved website performance, and fortifying their reputation in the competitive medical equipment industry.
Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD
Pharmacovigilance of Biologics in the USA (US FDA)
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from