SERVICE
We support CMC regulatory activities in pharmaceutical companies in all phases, from evaluation of investigational drug data at the time of initial clinical trial notification submission, evaluation of data for new drug application and support for preparation of documents to be submitted to the regulatory authorities, handling of regulatory review process until approval, change control management after approval.
Assessment of sufficiency of investigational drug quality data at the time of initial clinical trial notification (from US$10,000)
Assessment of sufficiency of investigational drug quality data at the time of initial clinical trial notification (from US$10,000)
We evaluate the sufficiency of investigational drug quality data at the start of the first clinical trial in Japan in light of Japanese pharmaceutical regulations, and if there are any deficiencies, we provide advice on how to resolve them.
Sufficiency assessment of quality data for new drug applications (from US$20,000)
Sufficiency assessment of quality data for new drug applications (from US$20,000)
We evaluate the sufficiency of data submitted when applying for new drug approval in Japan, and if there are any deficiencies, we provide advice on how to resolve them.
Support for preparation of documents to be submitted to authorities for new drug approval applications (from US$100,000)
Support for preparation of documents to be submitted to authorities for new drug approval applications (from US$100,000)
We provide support for preparation of documents (application forms and CTDs) to be submitted when applying for new drug approval in Japan (reviewing documents and preparing them on your behalf).
Responding to regulatory review for new drug approval applications (from US$50,000)
Responding to regulatory review for new drug approval applications (from US$50,000)
For new drug approval applications, we handle a series of regulatory review responses leading up to approval (advice on response policies, assistance with creating response documents, negotiations with reviewing authorities, etc.).
Support for post-marketing change management activities (from US$50,000)
Support for post-marketing change management activities (from US$50,000)
We support post-marketing change management activities related to manufacturing methods and testing methods for post-marketing pharmaceutical products.