Consulting for Regulatory

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

• l Planning for the application strategy
• l Research on precedent approvals
• l Construction inside the office accompanying revision of regulatory affairs (GMP, GQP, GVP)
• l Agency operation of contact proper authorities
• l Informing you of the required data for applications

Preparing the Application and Documents in Conformation to the

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

Preparing Documents for Clinical Trial in Japan

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

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

Preparing a Non-clinical Test Implementation

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

• Examining a biological safety test
• Examining an electric safety test
• Examining a physical performance test
• Examining a scientific safety test

Preparing Documents for End-user Surveys

We provide you with the best safety precaution protocol after device distribution into the market. We also help you with end-user surveys after deplyment.

• l Arranging an implementation plan for end user surveys
• l Arranging a survey report

Translating Documents from Overseas

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

Dispatching Regulatory Specialists

We also dispatch a regulatory specialist to your office from one day to more than six months according to your requirements.

Marketing Services

We provide you with analyzed distribution channel for new lines of product, and best circulation system.