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Regulatory matters

Support the application from specialist’s standpoint

Our specialists from non-clinical to clinical field will support your shortage in human resource to develop the pharmaceutical products.

We support the development of medicine generally from CMC to non-clinical and clinical studies (pharmacology, PKDM, toxicology). We also support the clinical study or application of the medicine or medical device based on specialist's standpoint.

The staff with extensive experiences and achievements will meet any needs in development.

Moreover, we can support you for long periods with a yearly contract.

If there are any problems in any stages of the development of pharmaceutical products or medical devices, please feel free to ask us for regulatory matters.

   Services related to pharmaceutical regulatory affairs

Assisting with Medical Device and IVD Regulatory Matters

•Preparation of Product Application File for Medical Device, IVD, Quasi-drug and
 Regenerative Product
•Support for the Inquiries and Answers from Reviewers / Authorities
•Development of SOPs for QMS / GQP, GVP, GLP and GCP
•Support for the regulatory inspection
•GMP / QMS Audit
•QMS Conformity Assessment

 

Consulting and Agency Service for Pre-Market Approval for Medical Devices, IVDs,

Quasi-drugs, Combination Products (Drug + Medicine) etc.

•Arrange Lab-testing with ISO / IEC / JIS test etc.

•Correspondence with Authorities

 (MHLW, PMDA, Tokyo Metropolitan Government and Notified Bodies)

 for the Application Review, Data Reliability, Site Audit and GCP Audit

 

Consulting or Agency Service for Clinical Investigations

•Provide Clinical Strategy and Study Design Negotiations with PMDA and Physicians
•Provide Protocol and other Essential Documentation
•Site’s IRB Approval. Site Agreement
•Project Management
•Data Management, , QC and Monitoring, Statistical Analysis and Final Reports

 

Consulting or Agency Service for CE marking and PMA/510k

•Prepare Technical Dossier/Technical File
•Clinical Evaluation, Software Validation etc....

 

 Do you have any problems with following aspects?

・We would like to have specialists to support us in a joint development of product or a development of introduced product.
・Would like to use the outside agencies since we cannot supplement the human
　resource.
　Since our staffs have abundant experiences in CMC, non-clinical studies and clinical
studies, we can support you in any sorts of documents preparation.

　The staff with abundant documentation experiences in each field takes charge of the

documentation service. Moreover, high quality documents could be prepared with the

thorough and accurate checking by staff before the delivery.