GPR can act as your local agent in Europe and assists medical device and pharmaceuitcal companies to register their products with the EMA.
The European Union (EU) has sought to strengthen access to medicines and medical products in response to weaknesses that came to light during the COVID-19 pandemic. New regulations that came into force today, place the European Medicines Agency (EMA) in charge of monitoring medicine shortages ...
The Medicines and Medical Devices Bill will look to implement a post-Brexit Medical Device registration modelled on the EMA MDR. The bill will allow harmonisation of regulations for Medical Device companies between other international bodies. Following the rescinding of approved bodies from the EMA, ...
Federal regulations prohibit FDA from acknowledging the existence of, or disclosing information contained in an Investigational New Drug Application (IND), unless that information has been made public by the sponsor. Having said that, we have seen a steady increase in the number of clinical trials ...
regulations were enacted, authorising the Ministry of Health and authorities to intervene to a considerable extent in the production and supply chains of pharmaceutical companies, medical device manufacturers and suppliers. Additionally, companies face export restrictions. While France, ...
This guideline explains the documents that should be submitted to demonstrate control of manufacturing and quality of the medicinal product in order to comply with applicable regulations. The medical device and/or part of a medical device (integral, co-packaged, or referenced) must comply with the...
It provides the whole range of control services - from raw material testing to stability testing according to GMP and ICH regulations. One of the main areas of competence and experience is also available for galenic dev... Product SKANFOG® STI - Sterility Testing Isolator Pharmalab india ...
The European Medicines Agency’s (EMA’s) role as one of the world’s leading regulators, which has been a major force in the drive to harmonize medicines regulations across the globe, could be seriously weakened as a result of the need to relocate its current London headquarters to Amsterdam...
Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions, such as cancer and autoimmune diseases. A biosimilar is a biological product that is very similar to an already approved biol
Subscribe FDA Labeling Requirements for Medical Devices Sheila J. Ramerman, RAC Founder Subscribe Complaint Handling in Compliance with FDA and ISO Regulations Jeff Kasoff, RAC, CQM/OE Quality and Regulatory Affairs Subscribe FDA PMA Submissions - Contents, Process, Pitfalls ...