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Regulatory Affairs

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Excellent Expertise for Your Regulatory Affairs 

To complement your drug development and shorten the time to market, Tigermed offers regulatory services for a wide range of products; from small molecules to biologicals and medical devices. Tigermed has successfully supported thousands of companies in both local trials and global projects and enabled them to provide solutions for unmet patient needs.

 

Regulatory Submission & Approval

Our regulatory experts have years of experiences with the FDA, NMPA, and the EU health authorities and are familiar with differences in local regulatory requirements. They can provide you with feasible strategies and act as liaison with various regulatory agencies, both on technical and regulatory issues.

  • Act as liaison
  • Dossier preparation, writing, submission
  • Dossier review
  • Maintenance
  • Feasibility assessments
  • RA / CMC 

 

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Medical Translation

Over the last 10 years, we have processed over 100 million Chinese characters for over 350 clients in hundreds of projects to provide them with high-quality medical translations. Our specialized translators have backgrounds in the life sciences industry to facilitate correct translation of any document.

 

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GMP Consulting

Establish a Qualified GMP Center

Many of our consultants are industry pharmacists and specialists who are familiar with the applicable quality standards and can help you design or adapt your quality and safety processes in order to minimize the risks involved in (bio) pharmaceutical production. Through these specialists, Tigermed is able to provide GMP consulting services to ensure US cGMP, EU-GMP, WHO GMP and Chinese GMP compliance.

Our services cover the entire life cycle of the GMP system, including the construction or renovation of factories / workshops, GEP consulting, qualification & validation, establishment of the GMP quality system, GMP training, internal audit, supplier audit, computerized system validation, official audit Support, CAPA response and findings closure.

 

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Regulatory
Strategy
in China

Thanks to our Chinese origin, we have successfully supported hundreds of companies to enter the Chinese market.

Global Reach & Local Expertise

*As of Q1 2020

We have successfully supported thousands of companies in local trials and global projects and enabled them to bring new drugs and medical devices to the market.