Regulatory Affairs Consultation

Consulting plan details

About consulting services

Regarding the consulting method, period and cost, we will propose the optimal plan according to the contents of each project and the wishes of the client.

Time-based contract

With a comprehensive consulting agreement, we provide consulting as needed and calculate the cost per hour per month.
If you have a monthly budget, you can carry over the expenses of the months that you have not used, so that you can sort them out to the months where you have a lot of regulatory work.

Project-based contract

Consulting is performed for each project at a fixed cost.
This is a recommended plan especially when a certain amount of time and product development costs are expected, such as when preparing an application for approval or in-person advice from PMDA.
Used by companies that want to temporarily enhance their regulatory resources.

Company visit contract

It is a plan to visit once a month or a predetermined number of times, and to make questions and questions related to pharmaceutical affairs and create materials on the spot. Regardless of whether or not there is a project, regular planning and review of regulatory affairs and support for the training of regulatory affairs personnel will help to continuously improve regulatory abilities.
In addition, if there is a case that requires urgent response, it is possible to shorten the time by responding in real time at the client's office.

The Regulatory Affairs Organization provides regulatory affairs consulting for medical devices.
For any requests or inquiries regarding the above consulting services, please do not hesitate to contact us via telephone or the inquiry page.

To request / inquiry form