Accessing the European Pharma Market: becoming a MAH through dossier adaptation (II)

The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged standards and requirements, it is not surprising the increasing interest of investors to this appealing market. When a non-European company is considering investing in EU business opportunities different strategies may be implemented depending on the company needs. One…

Accessing the European Pharma Market: becoming a MAH through dossier acquisition.

  Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s pharma market is becoming increasingly attractive, but accessing this market implies both regulatory and technical requirements, so different strategies need to be considered to ensure cost-effectiveness. One of the options available for companies seeking to…

Organic impurities

Organic impurities: ICH Q3A AND ICH Q3B

Introduction Identification and quantification of impurities in active ingredients and drugs products is a crucial aspect in pharmaceutical development to ensure the quality and safety of the product. Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient is considered an impurity. The presence…

Elemental Impurities ICH Q3D: Data and reality

The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a challenge for the pharmaceutical industry. Based on the document ‘Implementation strategy of ICH Q3D guideline’ (EMA/CHMP/QWP/115498/2017 – Committee for Medicinal Products for Human use (CHMP), there are two different approaches to risk management of elemental impurities…

SALUD, DEPORTE Y BIENESTAR

Más allá de la definición (repetidamente renovada) que la propia Organización Mundial de la Salud hace sobre ella (estado de pleno bienestar físico, mental y social, y no solamente la ausencia de enfermedad), parecería bien sencillo asociar los conceptos de salud y deporte con el de bienestar. Por subjetivo que sea este último y pudiera…