Central management of pharmaceutical approvals
Updated: July 2025, 10
At our company, we collectively manage the dates and information of pharmaceutical approvals that companies have obtained.
We provide a service that handles all the procedures related to permits and licenses.
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Characteristics of pharmaceutical-related approvals
- After obtaining a license, there will be surprise inspections (including seizures) by the Pharmaceutical Affairs Division.
- There are many procedures required after obtaining a license (procedures, shipping records, training records, etc.)
- During the renewal procedure, the revision status of the procedure manual and past records are checked in detail, and if there are any deficiencies, renewal may not be possible.
- Judgments differ depending on the jurisdiction, so it is essential to review the system even after obtaining permission.
Many companies, especially overseas cosmetics manufacturers, are choosing Japan as a destination for their expansion.Demand for pharmaceutical approvals in Japan is increasing..
On the other hand, depending on the results of irregular investigations by the Pharmaceutical Affairs Division,Severe consequences such as administrative penaltiesreceive orIf daily management is inappropriate, products will be forced to be recalled.etc,Risk of negative impact on the credibility of the entire companyin XNUMX minutes by bus from Yonago Station.
Nowadays, when compliance is being called out loudly, regardless of the size of the company,
"Let's review the management of pharmaceutical-related licenses and licenses to make them more effective."
"Let's create a system in advance that can withstand renewal surveys."
This movement is progressing rapidly.
Why not outsource all your permit management needs to a specialist?
Pharmaceutical-related licenses and permits include "New business, change, renewal, closure" In addition to other duties, "Preparation of procedures, legal records and agreements""Compliance with pharmaceutical regulations""Implementation of in-house training""Conducting a self-checkThere are several daily tasks that need to be done, such as:
Even in the renewal investigation of pharmaceutical-related licenses and permits,Procedure manual revision record"Or"Checking business records according to procedures""Ingredient inspection records”, as well as “Implementation status of in-house training/evidence thereof""Status of internal audit implementation/improvement response" These are now becoming review points to ensure the creation of a more effective system.
In addition to the renewal surveys, the Pharmaceutical Affairs Division also conducts surveys on an irregular basis.
If you can outsource the management of pharmaceutical approvals, which are different from other approvals, to us,It is possible to complete procedures inexpensively and reliably while minimizing the burden on your company..
Our company is based in Tokyo, Nagoya, and Osaka.Available nationwideHas become.
For companies with multiple locations across Japan, we also provide support in managing pharmaceutical approvals and licenses.We utilize our know-how on the responses and procedural flows required for each region, jurisdiction, and person in charge to quickly support advance preparations, coordination with authorities, and applications. international success.
We can also help with these types of problems.
``The renewal date is approaching, but there is no way to prepare because I don't know what will be investigated.''
``I haven't reviewed the procedure manuals etc. since I got the permit...I'm not sure if it will be compliant with the renewal...''
``The person in charge of managing pharmaceutical affairs suddenly retired, and the procedures were not easy...''
“In the future, we would like to expand not only to cosmetics but also to quasi-drugs and medical devices, but is this possible with the current system?”
Common license combinations
As for comprehensive management support for pharmaceutical-related licenses and licenses, we often consult with the following combinations of licenses and licenses.
We may be able to accommodate some of the other permits and permits, so please contact us separately.
Related licenses and permits
| Pharmaceutical affairs | Cosmetics, quasi-drugs, pharmaceuticals manufacturing/sales license, medical equipment |
| Others | Pharmacy/warehousing/health food |
For non-pharmaceutical approvals, click here
License and permit management general page
Support record (partial)
■Company A (listed on JASDAQ)
[Permission to hold]
Cosmetics and quasi-drugs manufacturing business (packaging, etc. classification)/manufacturing and sales business license
[Our business content]
Update/change procedures, review of procedure manuals, self-check support
After hearing about the license acquisition status, past management status, latest information, and future changes, we will formulate an annual plan and implement procedures according to that schedule.
*Support fees vary depending on the type of license, number of locations, etc. In addition, one-off requests are also possible.
First, please contact us by phone or email. (Consultations and estimates are free of charge.)
requestToBenefit
1. Specialist staff will assist you.
It is difficult for busy business owners to properly interpret and apply unfamiliar laws.
As legal experts, we will reduce your burden.
2. Quick and reliable response
Our motto is speed.
We have established dedicated teams for each project.
By systematizing it, we can respond quickly.
We handle your applications swiftly and reliably.
3. Consultation is free
We offer free consultation before placing an order.
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