Consulting for Japanese Pharmaceutical Affairs

We accept any consultations on the application for regulatory affairs to import and distribute of medical devices.
We serve you an appropriated strategy and an effective plan.

• l Planning for the application strategy
• l Research on precedent approvals
• l Consulting of Quality Management System and Safety Management System (QMS, GVP)
• l Reviewing of test reports (safety, efficiency)

Preparing the Application and Documents in Conformation to the Examining Authority (PMDA,RCB)

We arrange any needed documents on regulatory affairs. We help you with all kinds of services from one product to multiple products for your convenience.

• l Preparing application for approval of medical devices on the manufacture, distribution and import
• l Preparing standard manuals for products
• l Preparing application for overseas manufacturers
• l Preparing application for approval of product additions
• l Arranging the procedure for GQP and GVP
• l Arranging certificate of regulatory affairs

Preparing Documents for Clinical Trial in Japan

We arrange any needed documents for clinical trial according to the medical devices GCP.

• l Arranging clinical trial protocol and case card
• l Arranging clinical trial report / generalization report
• l Arranging product's outline
• l Arranging clinical study protocol

Preparing Non-clinical Test Implementation

We plan and implement non-clinical tests with collaborating examination organizations.

• Examining biological safety tests
• Examining electric safety tests
• Examining physical performance tests
• Examining a scientific safety tests

Translating Documents from Overseas

We translate any regulatory affairs documents from overseas.
We select the essential part of the application from the whole documents.
We provide you high quality regulatory affairs documents with a low price and short time.