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RELIABILITY ASSURANCE - 株式会社ファーマトリエ

RELIABILITY ASSURANCE

We create, review and store documentation that comply with reliability standards to ensure the reliability of your application to PMDA.

Ensuring reliability

The documents stipulated in Article 14 of the Pharmaceutical Machinery Law must be collected and prepared as shown below.

1 . It must have been accurately prepared based on the results obtained in an examine or test conducted to prepare the document.

 

2 . If an examine or test  in the preceding paragraph reveals that the quality, efficacy, or safety of the drug or medical device you are applying for is inadequate, we will evaluate it and include all results in the relevant document.

 

3 . The related documents that from the basis of the application documentation must be retained until the date of approval decision under Article 14 of the Act.

Reliability criteria for application documents

We will store and manage your documents while strictly adhering to the confidentiality agreement we have entered into with you.

We are building and updating our own database based on our development experience and global information gathering network. So we provide the latest and most reliable information in regulations and biopharmaceuticals development in Japan.

Consult with Pharmatelier about drug development

We will provide you with accurate and speedy support to solve various issues that may arise during
the development and application process.Please feel free to contact us.

Consult with Pharmatelier about drug development

Consult with Pharmatelier
about drug development

We will provide you with accurate and speedy support to solve various issues that may arise during
the development and application process. Please feel free to contact us.