For an importer of Asian medicinal products we assess whether the complete manufacturing process is in compliance with GMP, the contract and the European trade licence. For this assignment, we rely on our vast expertise of the various ways of administering and categories of medicinal products. Once product testing in a European laboratory yields satisfactory results, the product can be certified. The Qualified Person authorises the medicinal products to be released to the market.
A client distributing medical devices wished to expand this activity to include the distribution of medicinal products. They contracted us to act as Responsible Person based on our thorough knowledge of the requisites for obtaining a wholesale distribution licence. The existing quality management system, through a pragmatic approach and applying Quality Risk Management, was adapted to comply with the medicinal products’ legislation. The result? A successful inspection and a happy customer.
We joined forces with the Belgian branch of an international pharmaceutical company to work on a customised quality & compliance system. No large and rigid structures, but efficient and practical processes. We listened carefully to their needs, taking into account the norms and standards of the parent company. The close cooperation between us as RP/RIP and the company results in a gain of time and compliance for our client.
Another company asked us to assist its Responsible Person for Information. The company was seeking to simplify its procedures. These had grown so complicated that the sales team were no longer able to see the wood for the trees. Q-support streamlined all information and turned it into useful HOW TO documents to fit the company’s needs.
We start with an intake meeting to determine the customer’s activities and focus. We audit the customer’s distributor, haulier, supplier or manufacturer. For both routine audits and potential new contracts. We will assess whether the third party has an integral quality management system in place, in compliance with the directives and the customer contract. The audit is conducted thoroughly in order to be capable to provide our observations & recommendations in the form of a report.
Do any of these cases sound familiar? Interested in finding out how Q-support can advance your business? Feel free to contact us for an exploratory talk without any obligation.