As a consultant, we assist pharmaceutical businesses in designing structures and processes, as well as planning out specific courses of action. Our consultants' long-standing practical experience in the pharmaceuticals industry ensures that we always develop project-specific, professional and appropriate concepts.
rantronik offers pharmaceutical companies a broad spectrum of global consulting services and solutions covering the entire value creation process. Starting with drug development, rantronik supports your business in everything R&D, from carrying out preliminary planning, project approval and feasibility studies to cost-effectiveness analyses.
With regard to quality management, we provide you with advice concerning guidelines such as GMPs and SOPs, as well as CAPA management. To increase effectiveness and efficiency, we work together with you to optimise processes and structures in the production cycle.
Furthermore, we support you in carrying out clinical studies, all the way through to drug approval, always taking into account the constantly changing regulatory environment. We know the entire spectrum of strategic issues in the pharmaceuticals industry and support our clients in their efforts to make progress for the benefit of patients.
Patient safety and counterfeit protection by means of standards-compliant labelling, integration in existing production lines and compliance reporting.
Serialisation is used to provide global transparency, traceability, patient safety and counterfeit protection and in order to optimise order and supply processes. Under Directive 2011/62/EU on the prevention of falsified medicinal products, companies are required to unambiguously label and register pharmaceutical products and medical devices. Medicines without adequate labelling must not be circulated from the corresponding dates and will be considered counterfeits after that point.
Implementing serialisation requirements is a complex and time-consuming task with tight deadlines. It requires structural changes in the entire value creation chain, which are particularly challenging to realise for small and medium businesses. Investments in personnel, processes software and hardware must be made. On top of that, there are costs for certificates and evaluations, as well as security officers. rantronik has the required expertise to implement the requirements thanks to many years of experience with projects in the pharmaceuticals industry and medical engineering as well as access to the corresponding technologies. We advise you on the selection of the required hardware and software and the integration of new elements in existing plant and control systems in order to adapt the new packaging and labelling systems. In addition, we ensure communication with the appropriate authorities. In particular, this includes obtaining permits, the approval of the print layout, entry in the corresponding databases and compliance reporting.
Do you have any questions, or want to find out more?
Then please get in touch by telephone, e-mail or using our contact form – we look forward to hearing from you.