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Regulatory matters

Support the application from specialist’s standpoint

Our specialists from a non-clinical to a 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 trials (pharmacology, pharmacokinetics, toxicity). We also support the clinical trial or application of the medicine or medical device from specialist's standpoint.

The staff with extensive experience and achievement will meet any needs in development.

Moreover, the long-term support by a yearly contract is also possible.

If there is any problem in the stage of development of pharmaceutical products or medical devices, please ask for consulting.

  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 government 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 guide us with a joint development product and
 introduction product in the stage of consideration.
・Would like to use the outside agencies since we cannot supplement the human
 Since our staffs have abundant experiences in CMC, non-clinical trials and clinical
trials, we can support you in any sorts of documents preparation.

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

documentation service. Moreover, a high quality documents are prepared with the

thorough and accurate checking by staff before the delivery.