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TOKYO Pharmaceutical Company (TPC) has a long and successful career in pharmaceuticals, research and development and has an excellent working relationship with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).  Also, please note that TPC will be taking an active part in the medical development and regulatory affair business (because of TPC’s knowledge of speciality therapeutics). 

  

TPC was established in Nov. 2009, and is a drug-development consultancy, with professionals specializing in both clinical (including pharmaceutical regulation) and non-clinical drug development (including pharmacology toxicology).  

 

 

Project example 1: GAP analysis between dossiers submitted to FDA and requirements in Japan.

TPC’s regulatory affairs specialist will handle such project. Based on the results of GAP analysis, TPC will have a consultation to the PMDA as needed.

  

Project example 2：Investigation on market, competitors, NHI status, etc. For drugs marketed or under development in the Europe, US and others for the purpose of their introduction into the Japanese market.

TPC can provide such service. 

TPC has an expert for marketing research (MR) who had been working for MR at mega pharmaceutical company in Japan. TPC also has a contract staff who is a specialist of MR. 

If necessary, TPC will do select an organization for clinical trial or other required studies and manage them. TPC can also do an interview to KOLs (Key Opinion Leaders).

 

Project example 3: Investigation on classification of approval application for drugs and medical devices and preparation of registration dossiers.

TPC will provide such service for investigation of classification

For registration dossiers, TPC will prepare those dossiers using data and information provided by a client.

 

Project example 4: Investigation of regulations on cosmetics or quasi-drugs

TPC will provide such service.

 

Project example 5: Distributor search 

TPC has an expert for such project who has an experience as a responsible personnel for pharmaceutical/pharmaceutical raw materials contract manufacturing at a major chemical company. TPC itself has a strong network that is useful for such project.

  

Project example 6: Various requests from different clients

TPC will answer various requests. 

 

Note: All the TPC’s reports or documents are in Japanese that is the authentic form TPC can provide. If English translation is necessary, TPC will ask a professional translation company.

 

 

Pharmaceutical regulatory affairs expertise:

1.   Advanced interview  

2.   Face-to-face advisory counsel 

3.   Notice of Claimed investigational Exemption 

4.   Inquiry processing

  

Clinical development support

Review of development plan Timeline, budget, personnel plan, derivation, etc.

Assistance with clinical development

1. Investigator’s brochure (IB) 

2. Protocol amendment 

3. Patient survey 

4. Informed consent form 

 

Development of health food and food additive 

1. Reference and confirmation of food 

2. Safety Investigation (the toxicological study) 

3. Examination in human 

4. Investigation and gathering of related information  

 

Establishment of the company structure for drug development   

1. Institutional Review Board (IRB)  

2. Committee of safety assessment 

3. Medical ethics board of clinical trial (Company IRB) 

4. Compensation Board  

5. QC, QA
  

Formulation - development strategy, No.1  

1.  Product property, formulation study, non-clinical pharmacological and toxicological study 

2. Clinical study (P1-P3, notice of claimed investigational exemption and inquiry response) 

3. Liaison with regulatory authorities (advanced interview, face-to-face advisory counsel, notice of claimed investigational exemption)  

4. Establishment of company management system Formulation of SOP for GLP, GMP, GCP 

5. Proposition of the budget of research and development and personnel plan.  

6. Experts feedback 

7. Support and establishment of more efficient development strategy 

 

Formulation: development strategy, No.2 

1. Conformation and identification of product property. 

2. Formulate design, test production, examination of several properties, and client search. 

3. Advise on design and operation of non-clinical study (especially pharmacological and safety study). 

4. Consultation and liaison with the authorities about the plan of clinical trial and notice. 

5. Preparation of the investigator’s brochure protocol amendment, patient survey, the informed consent from, and consultation of personnel plan and budget.

  

Accommodation to the authorities 

The pharmaceutical affairs-experienced consultants will support the following contents by advising, which are significant in terms of the notice application. We will contribute the information from the experts of QC and QA.  

1. Advanced interview  

2. Face-to-face advisory counsel 

3. Notice of Claimed investigational Exemption 

4. Inquiry processing 

5. Confirmation of consistency of data 

6. Application for manufacturing approval 

7. Application linking development of orphan drugs 

8. Support of application to the public funds and its operation  

 

The partnering companies 

Experience at establishing alliances with partner companies 

Experience evaluating drug patents 

We have actualized the advice and support of practices.  

Practical accomplishment 

Development of new drugs 

1. Anti-inflammatory drugs and analgesics/Oral medicine, External preparation (embrocation and adhesive patch)                                                    
2. Anti-rheumatoid drugs/antifolate, anti-TNF-α  

3. Anti-microbial drugs 

4. Influenza vaccine 

5. Anti-hyperphosphatemia drugs 

6. DDS preparation 

7. Health food 

  

Practical accomplishment

Establish the system of research and development 

1. Preparation and operation of SOP for GCP compliance for clinical trials 

2. Application of several orphan drugs 

3. Establish the system of development of research, clinical trials, and establishing various committees (Institutional review board, medical ethics board, safety evaluation committee, compensation evaluation committee, etc) 

4. Application of public funds and their practice 

5. Preparation of Clinical Trial Notification 

 

Your generic products in Japan into the European Union (EU) market

Japanese pharmaceuticals have a good reputation for high quality. 

The EU health care market is placing an increasingly high weight on the use of generics. 

1. The role of TPC is to help Japanese Pharmaceutical Companies export and commercialize your generic products into the EU.  

2. TPC has acquired expertise on the regulatory conditions for the approval of generics in the EU. 

3. TPC has developed a network of contacts with professionals actively involved in regulatory affairs for generics in the EU. 

4. TPC has developed a network of professionals located in the EU with hands-on experience in marketing generic products. 

5. TPC is able to guide you to distributors and wholesalers covering the entire EU area. 

Inquiry：info@tokyo-pharma.co.jp