Expanding Horizons: Rook Quality Systems Now Offering Product Registration and License Holding Services in APAC

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At Rook Quality Systems (RookQS), our mission is to provide unparalleled regulatory and quality support to the medical device industry. We’re excited to announce the expansion of our services in the Asia-Pacific (APAC) region to include product registration and license holding. This expansion enables us to better serve clients within the APAC region, ensuring a seamless entry into these dynamic markets.

Comprehensive Support for APAC Market Entry

Navigating the regulatory landscape in the APAC region can be complex, with each country having distinct requirements and standards. Our new product registration and license holding services are designed to simplify this process, providing expert guidance for a smooth market entry. We also have local partners who can support reimbursement strategies, further streamlining your market access. Whether you’re launching a new product in Korea, expanding in China, or entering markets in Singapore and Australia, Rook Quality Systems is here to assist you every step of the way.

RookQS Service Offering

In addition to our new services, RookQS continues to provide a comprehensive suite of quality and regulatory services, specifically tailored for the APAC market:

  • Technical Dossier and Technical File Drafting: Our team excels in drafting precise and comprehensive technical files that meet regulatory standards, ensuring efficient approval processes.
  • Regulatory Submissions: With a deep understanding of the regulatory frameworks across various APAC countries, we assist in preparing and submitting regulatory applications, helping you achieve compliance swiftly.
  • Audit Support: We offer extensive audit support services, including pre-audit preparation, on-site support, and post-audit follow-up. Our goal is to help you maintain compliance and uphold the highest quality standards.
  • Remediation Services: If you encounter compliance challenges, our remediation services are designed to address these issues, update technical documentation, and ensure alignment with current regulatory requirements.
  • Quality Management System (QMS) Support: We assist in the design, implementation, and maintenance of robust QMS tailored to your specific needs, ensuring adherence to international standards such as ISO 13485.
  • Regulatory Strategy Development: Our experts develop comprehensive regulatory strategies, guiding you through the complexities of the APAC regulatory landscape and helping you make informed decisions for successful market entry and compliance.
  • Training and Education: We offer specialized training programs in QA/RA, keeping your team informed about the latest regulatory changes and best practices in the industry.

Proven Expertise in the APAC Region

RookQS has a strong track record of supporting clients across the APAC region. Our extensive experience covers a diverse range of markets, including Korea, China, Japan, Taiwan, Singapore, New Zealand, and Australia. We understand the unique challenges and opportunities in each of these markets and are committed to providing tailored solutions that meet the specific needs of our clients.

Why Choose Rook Quality Systems?

Our team comprises experts in medical device regulatory and quality, bringing a wealth of experience and knowledge to the table. We keep our clients informed and prepared by staying up-to-date with the latest regulatory developments and industry trends. Choosing RookQS means partnering with a company dedicated to your success and committed to delivering the highest level of service.

We are excited to expand our services in the APAC region and look forward to helping more companies achieve their regulatory and market goals. For more information on how RookQS  can support your business, contact us today!

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