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Recently, the drug development is time consuming and costly. When all is said and done, only 1-2 of the 100,000 molecules, actually reach the market for therapeutic uses after development times of 7-12 years (or more) and costs that can reach $ 1.5 billion before the NDA is filed. Thus pharmaceutical companies have placed top priority to speed up of drug development and NDA within a defined time frame. In addition, pharmaceutical companies have suffered with the increasing failure rate of new drugs during development process, i.e. the failure rate of new drugs entering phase 2 today have more than 80% chance of reaching the market .

 

The basis for the marketing approval of drug products is safety and efficacy. To this end, the “ road map “ to develop drug products is both defined and regulated by the regulatory bodies. However, pharmaceutical companies have faced many different problems to be solved during drug development.

 

Regulatory Science Institute, Inc. (RSI) provides services on research /survey of regulations and consultancy on drug development to help pharmaceutical companies solve problems, and conduct more scientific and efficient drug development

Our Services

Global Guidance Research Net (GGSN)

You can easily search guidances and related information (abbreviated as guidances) on development of pharmaceutical products by using GGSN.
GGSN covers about 1800 guidances issued by MHLW (Ministry of Health, Labor and Welfare in Japan), USFDA, EMEA and ICH. Pharmaceutical products are classified into main 3 categories, DRUGS (conventional molecules), BIOLOGICS (biological products with high molecules) and GENERICS.

APPLREVAPR
Application, review, approval, etc
EFFICACY
Clinical studies
QUALITY
Control, manufacturing and control of drug substances and drug products, etc
SAFETY
Nonclinical studies (toxicology, pharmacology, safety pharmacology, pharmacokinetics)

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Drug Information Research Net Approved by MHLW, USFDA and EMA

You can easily research information (review classification, therapeutic area, pharmaceutical form, etc.) of medicinal products authorized by MHLW/PMDA, USFDA and EMA, and get access to their approved reports or label.

a) MHLW/PMDA Authorized Product Information Research Net (MHLWAPIRN): This Net is only Japanese version.

MHLWAPIRN covers 583 medicinal products listed in the PMDA website (1999-2013 March).  This data base includes drug price information.

Go to the Outline and Instruction for use of MHLWAPIRN

b) FDA Authorized Product Information Research Net(FDAAPIRN)

FDAAPIRN covers 1500 medicinal products listed in the USFDA website (1998-2013 March).

Go to the Outline and Instruction for use of FDAAPIRN

c) EMA(EC) Authorized Product Information Research Net(EMAAPIRN)

EMAAPIRN covers 656 medicinal products listed in the EMA website (1995-2013 March).

Go to the Outline and Instruction for use of EMAAPIRN

Consultation

RSI provide the following consultancy services to help sponsors conduct efficient drug development and solve issues.

  • ・Research and survey of regulations and approved drug information on drug development
  • ・Drug development
  • ・Review and evaluation of documents and data for application

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