Regulatory Science Institute .Inc Thank you for your access

Regulatory Science Institute .Inc Thank you for your access

Regulatory Science Institute .Inc Thank you for your access

Anyone can use the search functions covered in the homepage as to the guidelines
and new pharmaceuticals without charge.

Guideline Update Information Date of update:2017/01/05

 
APPLREVAPR
EFFICACY
QUALITY
SAFETY
MHLW
3
1
 
 
USFDA
3
4
4
1
EMEA
 
6
4
1
ICHI
 
 
 
 
 
APPLREVAPR
EFFICACY
QUALITY
SAFETY
MHLW
 
1
1
1
USFDA
1
2
 
 
EMEA
 
1
 
 
ICHI
 
 
 
 
 
APPLREVAPR
EFFICACY
QUALITY
SAFETY
MHLW
 
 
 
 
USFDA
2
 
 
 
EMEA
 
6
 
 
ICHI
 
 
 
 

Philosophy of Regulatory Science Institute, Inc.

Philosophy of Regulatory Science Institute, Inc.

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,

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Buisness

Global Guideline 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 3950 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.

The guidelines are classified into the following 4 fields.

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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Consultation

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

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コンサルタントの内容

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