Who We Are

Pacific-Link Consulting has coordinated regulatory and clinical development programs in Phases I – IV for more than 10 years. We have worked with more than 100 pharmaceutical and biotech companies, including many of the top 10 large pharma companies. PLC is headquartered in San Diego with offices in Tokyo, Japan and our partner company (Sirius Regulatory Consulting) in London, England.

Our key areas of expertise include:

Strategic development for biologics and pharmaceutical products

Regulatory interactions and strategy for US, Japan, EU and Canada (global development)

Project management

CMC support – quality and supply chain

Regulatory compliance and audits

Clinical trial development and site management

Business development and value maximization strategies

Support of due diligence reviews for companies and venture capital groups

Advertising and promotion

Utilize Actua Software for full electronic regulatory submissions internally

News & events

PLC, and our London based Partner Sirius Regulatory Consulting, today announced that the European Medicines Agency (EMA) has granted Orphan
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Pacific-Link Consulting today announced the establishment of Pacific-Link Consulting KK (PLC-KK), an affiliated kabushiki kaisha based in Tokyo, Japan. The
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Pacific-Link Consulting (PLC) is proud to announce that the Japan External Trade Organization (JETRO) has appointed Richard Lowenthal MS MBA,
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