Regulatory Affairs
We provide professional consulting services and dossier preparation for product-registration services for pharmaceuticals, medical devices and biologic products.
All our staff has long experience in medical field. The knowledge of over 500 submissions can provides you the best solution. The best strategy is in your hand by our support.
１．Building Regulatory Strategy
Build the best Regulatory strategy by understanding your product and technology, and provide the quickest and reasonable process for regulatory clearance. The plan includes negotiation strategy with authority.
2．Preparation of Dossier
Execute documentation work with available data. If you already have approval in your country and/or other ones, those can utilize to the submission in Japan as well. We will promptly analyze the material you provided and prepare the best Dossier for Japan authority to accept.
3．After Care
We will do our best to obtain approval. However, if there is any problem observed, please direct us.
We have a fund return policy. （It is out of scope the loss or issue comes from your lack of data etc.）
We will also continuously watch your registration and assist the change of your product or regulation, and quickly up date the Dossier by partial change submission etc.