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
