SOURCING / QUALITY ASSURANCE / MANUFACTURING

Medical companies are increasingly looking to Asia for their sourcing and manufacturing needs in order to take advantage of relatively low labor and production costs and proximity to large markets for their products. This involvement can range from sourcing of products, components, and raw materials, to contract manufacturing, to manufacturing locally in Asia. Medical companies can oftentimes gain significant cost savings by sourcing products or employing contract manufacturers overseas. Medical companies that manufacture locally in Asia can tailor their products (if necessary) to meet the specific needs of the local market, with opportunities for input from relevant members of the Asian medical community.

However, there are also challenges that come with doing business in Asia. Language barriers may make clear communication difficult, particularly during a discussion of technical specifications or other manufacturing requirements. Medical companies will also have to navigate cultural differences and gain a better understanding of Asian business practices. Quality assurance and control will be essential to ensuring that the products meet your standards and specifications.

PBM can assist medical companies with all aspects of sourcing, quality assurance, and manufacturing in Asia. We have recently set up our own dedicated office in China specializing in these services.

SOURCING

Many finished medical products and components can be sourced in Asia. PBM provides assistance and guidance through every step of the sourcing process to achieve lower manufacturing costs while maintaining your high product quality standards. We can help identify the right companies in Asia to source from, as well as help your company to develop long-term business relationships with them. We will also serve as your liaison to address every logistical, technical, or cultural issue that may arise during the sourcing process to ensure that it goes as smoothly as possible.

This service entails:

• Finding suppliers in your product areas;
• Accompanying you on factory or office visits with potential suppliers;
• Liaising with suppliers to procure samples and communicating and discussing your technical requirements;
• Coordinating alterations of product specifications to meet your needs;
• Handling all logistics and project management entailed in the sourcing project;
• Negotiation of the contract; and
• Implementation and enforcement of the contract, including quality assurance and control at the factory site.

PBM has its own office in Beijing to assist clients with sourcing medical products in China. Our location in China gives us on-site presence and enables us to meet face-to-face with suppliers. Our staff includes bilingual English and native Chinese speakers who understand Chinese business practices and who can ensure that all of your needs and requirements are communicated clearly. To learn more about sourcing in China, please see our article "Eight Simple Rules for Outsourcing to China".

QUALITY ASSURANCE AND CONTROL - CHINA

Whether you are sourcing or manufacturing finished medical products or components in Asia, quality control is a key issue. Although it may be cheaper to source or manufacture medical products overseas, there is no reason to do so if the product quality does not meet your requirements on a consistent basis.

PBM’s Beijing office is equipped to provide quality assurance and control services at every step of the sourcing or manufacturing process. We have a bilingual staff of English and native Chinese speakers who have worked in technical fields and have training in quality assurance and control. Our quality assurance and control experts are available to conduct factory site visits to ensure that your quality standards are met. PBM will monitor production runs and make sure your container is properly loaded on site.

Our quality assurance services include:

• Performing background checks of potential suppliers’ reputations;
• Conducting factory visits to check the quality of facilities and equipment;
• Meeting with suppliers to ensure that all technical specifications and requirements are communicated and implemented accurately;
• Ensuring that medical products meet regulatory requirements and quality standards like ISO 13484, GMP, and GCP;
• Assisting with quality checks of products; and
• Following up with suppliers if quality issues arise.

MANUFACTURING

Manufacturing your medical products in Asia may be an important strategic move. If you sell to Asian markets and already source components from Asia, it may be worthwhile to set up your own factory in Asia.

PBM can help you devise entry strategies to manufacture and market locally to Asian markets. We have a network of in-country partners throughout Asia who can assist you with setting up your own factory, and who are familiar with local laws and regulatory procedures. To help you build a successful venture, we can also introduce you to trustworthy distributors and help develop marketing plans for your products.

PBM can provide the following manufacturing services:

• Identifying the appropriate country and site for your manufacturing facility;
• Scouting factory locations and building sites;
• Interpreting local laws and regulations that govern local business practices;
• Contract negotiation for your new facility;
• Assistance with implementing GMP, ISO, and other regulatory standards;
• Identifying distributors; and
• Developing marketing strategies.

Contact us to learn more about how we can help you!

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