Quality Assurance and Regulatory Affairs

BeForPharma offers its clients an exclusive quality assurance service, able to manage all the procedures and regulatory aspects of production

An effective and safe radiopharmaceutical, suitable for administration to patients, is first and foremost a quality drug. Quality is not an abstract value but an integrated and complex organizational system, formalized in a Quality Assurance System. The task of quality assurance is therefore to oversee the entire production chain, verifying continuously that the pre-established quality standards are always respected. Quality assurance provides control over the management and correct compilation of documentation to support the entire life cycle of the drug, the continuous verification that established procedures are being implemented, and the management of all the production activities essential to guarantee a quality product and comply with current regulations – such as training personnel, disposing of hazardous waste, managing deviations and changes (to name but a few). The technical-regulatory apparatus of the pharmaceutical sector is extremely complex and constantly evolving. Authorization procedures for the use and marketing of drugs require numerous steps and the support of a specific competent figure, the Regulatory Affairs specialist. Regulatory affairs specialists are responsible for overseeing the whole series of authorizations necessary for pharmaceutical production, and applying the regulations so that applications for authorization can be presented correctly. In this way they act as intermediaries between the pharmaceutical company and the authorizing institutions.