At TRAQuE we understand the regulatory minefield that you need to negotiate to achieve and maintain your products on sale in the global pharmaceutical markets.
|Finding, understanding and implementing the regulations can be a significant hurdle in achieving GMP certification. Target market requirements differ, and what might be acceptable in some countries may be contradicted by regulations in another country. Our experts have many years of experience in supporting customers to achieve compliance in multiple countries and regions.|
|Our experts have years of experience helping numerous companies achieve regulatory clearance to sell their products. We have extensive experience navigating the right path to regulatory approval. Our team can work with yours to bring them up to date on the latest requirements and expectations.|
|We have supported companies with continuous improvement projects, remediation work, and in responding to warnings and citations. Even if you know your regulations, implementing them in a practical and maintainable way can be difficult. We can help by giving you the right expertise and baselines so that you can continue to meet them.|
|We have worked with multinational corporations and small local companies in markets from China to Palestine, Japan to India, and Europe to the US. Our experience is global, but our knowledge is local. Whatever your target market, we can help you achieve compliance.|
|We can support you in the following activities: |
|We can give you practical and hands-on support in many activities, including |
|We can help prepare practical and compliant SOPS including: |
|We can help you with your laboratory computerized systems, and give you practical advice and solutions on: |
If you would like more information, please "Get On TRAQuE" and contact us.