これまでにこんな相談に対応しています。
Product development and regulatory/legal compliance
これまでにこんな相談に対応しています。
Product development and regulatory/legal compliance
Investigation of overseas documents to compare with Japanese requirement (GAP analysis)
Support to obtain licenses of the new products for Japanese market.
Support for getting licenses for manufacturing veterinary medicinal products.
GMP training and regulatory support
Compliance and GXPs training.
Support communication between overseas companies and Japanese agents.
これまでに様々な資料作成のお手伝いをしています
Support for preparing various documents
Preparation of documents required for application for approval of new veterinary drugs including general drugs, vaccines, biopharmacy, etc.
Creation of materials such as manufacturing and sales business, manufacturing license application, overseas manufacturer certification, etc.
Creation of application for approval of changes to existing products, notification of minor changes, etc.
Preparation of adverse event reports for existing products, drug use-results surveys, literature surveys
In-house training on compliance and creation of SOP
Translation of VICH guidelines.
まずはできる限り詳しいご相談内容を弊社ホームページからご相談下さい。
First of all, please contact us from our website for the details of your consultation.
ご相談内容いただいた内容に関して担当者よりご連絡差し上げます。
更に踏み込んだ内容をお伺いし、弊社でお手伝いできる事ことをお伝えします。
(この時点でNDAを締結することも可能です)
The person in charge will contact you regarding the content of your consultation
We will ask you about the details and tell you that we can help you.
ご相談内容から業務量などを算出し、かかる費用をお見積もりいたします。
We will calculate the amount of work from the content of the consultation and estimate the cost.
お見積もり内容に同意いただけましたら、正式に契約書を締結いたします。
If you agree with the quotation, we will formally conclude a contract.