If you manufacture products for markets beyond your own, ensuring regulatory compliance can be a particular challenge: from staying up to date with changes to navigating language barriers, or even meeting requirements above the official guidelines. That’s why our one-stop regulatory support provides you with everything you need in a fast and convenient way. Whether your needs are more straightforward, or you require dedicated support, our expert team is here to take the complexity and risk out of regulatory compliance for your whole product lifecycle.
Meeting changing regulatory requirements
We proactively monitor new requirements, guidelines, and trends to ensure you have all the necessary documentation and answers to your questions. We understand that local regulations can pose a particular challenge, and provide specialist support here. For example, since in some regions it can take up to a year to get an official English version of local regulations, we are able to respond quickly to these changes by collaborating with our distribution partners and network to access translations.
While many countries are working towards harmonizing regulations, our experience shows that some customers still require more documentation than officially specified. We collaborate closely with our customers and local authorities to get a better understanding of these requirements and ensure compliance.
Draw on our network of knowledge
We maintain a very close dialogue with our customers to support them with their regulatory requirements, with tailor-made support for each. If you work with an outsourced contract research organization or contract manufacturer, we can coordinate with multiple external partners, while providing you with a single point of contact from our end.
In addition to our strong relationships with our customers and local authorities, we network with similar companies in Europe, organizations, and forums, and stay up to date with conferences. We have access to information from specialists and libraries to help us monitor and prepare for new trends and regulations.
A one-stop, tailored support package
We provide a one-stop compliance and regulatory package, providing you with up-front access to certificates from authorities (including cGMP, ISO 9001, 14001 and 45001), qualification dossiers, statements and declarations, stability and analysis documents, and much more. This comes from our dedicated QA and regulatory affairs teams, who draw on their knowledge and many years of experience to provide our customers with premium support and service. These teams are all gathered on our one site in Europe, together with all our manufacturing and business operations. This allows our teams to work together to quickly respond to trends and changes in requirements – and to your questions and requests.
We support our customers well after supplier qualification and delivery and through their whole product life cycle in case of any problems or issues. We have a clearly defined change notification process for communicating changes to our processes, analysis, raw materials or specifications. Documentation is maintained individually, and customers can decide how often they need dossier updates submitted to authorities.