Market access for medical devices: Challenges and potential Solutions

whitePaper | February 24, 2023

A new way of thinking and working has evolved for the discovery of therapeutic antibodies. Until recently, large numbers of antibodies were generated, only for a relatively small fraction to be sampled and engineered for further lead generation.

whitePaper | June 15, 2022

To date, therapeutic advances in treating central nervous system (CNS) disorders have been incremental at best. As the global population increases and older demographics begin to make up a disproportionately larger percentage,

whitePaper | December 5, 2022

Serialisation has emerged as a complex challenge for the pharmaceuticals sector which is facing a multiplicity of differing regulations that vary from one country to another.

whitePaper | May 22, 2021

One of the key roles of the generic and biosimilar medicines industry is specifically to promote the widest possible access to affordable medicines with high quality, safety, and efficacy for patients globally by introducing competition into the markets. Despite the many hurdles, the generic medicines companies have clearly lived up to the challenges posed by the pandemic as it is an industry that is quick to adapt and agile in manufacturing scale-up. During the outbreak of COVID-19, this industry was providing most of the medicines needed in Intensive Care Units to ventilate critically ill COVID patients. It is also providing most of the quality medicines dispensed around the world, especially for increasingly prevalent chronic diseases and is therefore a strong contributor to health outcomes globally.

whitePaper | July 11, 2022

The expansion in the development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs) and complex active pharmaceutical ingredients (APIs) has grown tremendously as demands in healthcare to bring newer therapies to market quicker increase.

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.