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Regulatory affairs

Robert Koller

Senior Director, Global Regulatory Affairs, Performance Materials

+41 44 386 7272
Fax +41 44 386 7610
Contact Email
DKSH International Ltd.
Wiesenstrasse 8
8034 Zurich
Switzerland

Michael Hofer

Regional Market Expansion Services Manager

+66 2 220 9733
Fax +66 2 220 9843
Contact Email
DKSH Management (Thailand) Limited
2106 Sukhumvit Road, Bangchak, Prakhanong
Bangkok
Thailand
  • Factsheet Performance Materials
    (PDF, 143 KB)
  • Safety, Environment, Quality & Regulatory Affairs brochure
    (PDF, 3 MB)
DKSH Regulatory Services blackboard

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.

In Healthcare and Consumer Goods

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:

  • Market attractiveness assessments
  • Regulatory feasibility assessments
  • Product launch planning
  • Market entry planning
  • Artwork and labeling consulting

  • Dossier preparations
  • Compliance checks
  • Dossier submissions
  • Registration follow-up and monitoring
  • Product sample submissions
  • Regulatory approvals

  • Marketing Authorization (MA) holding, maintenance and transfer
  • Variations (minor and major)
  • Renewal
  • Advertising compliance checks

  • ACTD compilation and reformatting
  • Safety monitoring programs
  • Liaison with regulatory authorities
  • BA/BE studies support
  • Dispute resolution
  • Regulatory compliance management
  • Pharmacovigilance
  • Clinical import licenses
  • Technical services

  • Special / temporary import licenses
  • Compassionate program and patient basis supply import licenses
  • Authorities reporting
  • Data exclusivity
  • Legalization and notarization
  • Company registrations
  • Product recall support
  • Counterfeit monitoring

In Performance Materials

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.

Compliance

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.

  • We have global reporting systems to ensure compliance at all levels, offering information that is used in our key client reports
  • Safety officers set the highest standards for global safety concepts and deliver professional risk assessments to guarantee compliance with safety regulations for manufacturing, transport, warehousing and handling of chemical compounds
  • Registration specialists support our business partners with value-added product registrations and full documentation
  • Quality auditors conduct independent supplier audits and certifications to comply with industry standards and customers’ requirements

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:

  • Safety audits and inspections
  • Classification, labeling and packaging
  • Safety data sheets
  • Global Harmonized System support

  • Supplier pre-audits and audits
  • Supplier qualifications and certifications
  • Change controls
  • Claims management

  • REACH services
  • Regulatory strategies
  • Registration management

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.

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