With global business comes global responsibility. Our dedicated team of regulatory affairs and compliance experts help our partners within healthcare and consumer goods industries register their products and overcome regulatory challenges to secure their growth in Asia. We also serve our business partners in compliance with all applicable regulations for safety, health and the environment required in the performance materials industry. Actively managing quality assurance and registrations helps our clients build competitive advantage in their respective markets.
DKSH provides specialized regulatory consulting and registration services across Asia for pharmaceuticals, biologicals, over-the-counter (OTC) and consumer health products as well as medical devices, food and veterinary products.
Our team of more than 70 regulatory affairs experts build on their strong scientific and industry background to ensure that our clients’ products are registered efficiently and in a compliant way. We provide our clients with broad technical registration expertise and in-depth knowledge of local regulations. We also maintain ongoing liaisons with regulatory authorities, manage our clients’ dossiers, hold a large number of marketing authorizations on behalf of our clients and safeguard their interests. Our business partners benefit from having a single regional point of contact for all regulatory matters.
We offer the following services:
As part of the DKSH Business Unit Performance Materials, our regulatory affairs experts are an integral part of the DKSH Market Expansion Services package, handling compliance, registration and documentation for clients and customers. Part of this is our special competency center for the European REACH regulation which, along with our many other compliance competence centers all around the world, provides effective support for our business partners.
Full compliance for safety, health and the environment, as well as quality assurance and added value registrations are top priorities at DKSH. Our highly qualified experts manage all aspects of regulatory affairs, set policies, define clear rules and set standards to enhance reliability and compliance. We have the resources and expertise to anticipate future regulatory needs to support your business.
Global presence and local knowledge
DKSH has seven established quality and regulatory affairs competence centers around the world in order to leverage our accumulated global experience and knowledge for the benefit of our business partners.
We offer the following services:
The Supplier Agreement Program (SAPA) is a new, unique service designed by DKSH to conduct supplier auditing and certification. This service assures our customers that the products they source from us are delivered to specification and ensures consistent quality and sustainability. With SAPA in place, customers can rely on our work and at the same time reduce non-compliance risks, recalls and major deviations. Ultimately, we can help improve our suppliers’ businesses and products and by doing so, both our suppliers and our customers can gain professional credibility in their markets.
In 2007, a new and very strict chemicals regulation took effect that fundamentally changed chemical control in the EU. In response, DKSH offers coordinated action from both the regulatory affairs and business sides, and a proactive way of dealing with those challenges. Critical factors are business-driven decisions combined with regulatory expertise. The deep industry knowledge of our REACH experts and the leverage of our global DKSH networks are a real competitive advantage for everyone affected by the legislation.