Bridging the gap in your Phase I clinical studies. 

Japan’s pharmaceutical market is the second largest in the world. Japan relies on the import of pharmaceutical goods to meet the needs of the country’s population. To capitalise upon these opportunities, drug developers must comply with the strict Pharmaceuticals and Medical Devices Agency (PMDA) regulations. 

Richmond Pharmacology’s expertise can help you bridge the gap in your next Phase I clinical study.

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Learn about the bridging studies conducted at Richmond Pharmacology

A single centre study for Chiesi Pharmaceuticals. 16 Japanese and 16 Caucasian volunteers participated in cross over, bridging study for Chronic obstructive pulmonary disease. Read about our approach and the controls we introduced to reduce variability. Learn more here.

A cognitive function profile of a second generation antihistamine. The effect of rupatadine on cognitive functioning was evaluated by means of computerized cognitive tests: rapid visual information processing (RVP), reaction time (RT), spatial working memory (SWM) and visual analogue scales (VAS) with 27 Japanese volunteers. Learn more here.

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Why choose Richmond Pharmacology for your Bridging Study

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Expertise in PMDA criteria

We have conducted more than 100 ethnic bridging studies enabling us to build a trusted relationship with the PMDA.

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13,000 active 1st generation Japanese subjects

Our recruitment database is the largest in Europe with more than 13,000 active 1st generation Japanese subjects. 

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Short- and long-term residency periods

We can accommodate studies with short-term and long-term residency periods.

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Richmond Pharmacology's ethnic bridging studies will reduce the PMDA approval timeline and accelerate your time to market.

Latest news

Director of Operations, Keith Berelowitz, has been appointed as the Research Ethics Committee Chair for the Health Research Authority.

January 19, 2023
Keith Berelowitz will be responsible for ensuring that all ethical possibilities are explored in relation to new research.
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Unlocking the potential of data sharing

January 4, 2023
Dilshat Djumonov explores how GDPR is central to protecting private information while presenting unique challenges to the pharmaceutical clinical trials industry.
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Events

13th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions

Sunday, June 4th to Tuesday June 6th 2023
Exchange research-based knowledge on drug-drug interactions (DDIs) among all interested stakeholders from pharmaceutical industry, regulatory authorities, academic and health care delivery backgrounds and perspectives.
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