Regulatory Dossiers - Until recently, for each country or region, the information generated during drug development (i.e. study results, details of manufacture and legal/admin info) had to be documented in so-called regulatory dossier. This dossier was to be organized in accordance with country-specific national requirements and submitted for review by National Health Authorities. Read more
Pharmaceutical Development - Pharmaceutical Medicine covers all aspects of Research & Development, Manufacturing, Registration, Marketing & Sales and Pharmacovigilance concerning medicinal products.
Just as in the aviation industry, the pharmaceutical industry is heavily regulated to serve customers safety. The regulation includes guidance on how to assure a consistent quality of the medicinal product and how to assess the benefit-risk ratio to the patients. Read more