Pacific-Link Consulting
Pacific Link Consulting is a comprehensive consulting firm specializing in regulatory services, clinical trial management, product development, and business development for pharmaceutical, biotech, and medical device companies. With over 10 years of experience, they support clients in the US, Japan, Europe, and Canada, helping them navigate complex regulatory landscapes, develop strategic plans, and bring innovative medical products to market.
Industries
Nr. of Employees
small (1-50)
Pacific-Link Consulting
Rancho Santa Fe, California, United States, North America
Services
Strategic regulatory planning, agency meeting facilitation, and preparation, review and filing of regulatory submissions for US and European markets.
Japan-focused regulatory planning including bridging strategies, local agency interactions, KOL liaison and filing support through a Tokyo-based office.
Full-service clinical trial support including protocol development, site start-up, site and vendor management, clinical study report development and site close-out across Phase I–IV studies.
Pharmaceutical development support including CMC advice, quality and supply chain guidance, and business development input for product lifecycle decisions.
Identify potential partners and investors, perform due diligence, prepare partnering materials, and develop market-entry and licensing strategies including regulatory assessments and risk evaluations.
Strategic regulatory planning, agency meeting facilitation, and preparation, review and filing of regulatory submissions for US and European markets.
Japan-focused regulatory planning including bridging strategies, local agency interactions, KOL liaison and filing support through a Tokyo-based office.
Full-service clinical trial support including protocol development, site start-up, site and vendor management, clinical study report development and site close-out across Phase I–IV studies.
Pharmaceutical development support including CMC advice, quality and supply chain guidance, and business development input for product lifecycle decisions.
Identify potential partners and investors, perform due diligence, prepare partnering materials, and develop market-entry and licensing strategies including regulatory assessments and risk evaluations.
Expertise Areas
- Regulatory strategy and submissions (US, EU, Japan, Canada)
- Clinical trial management (Phases I–IV)
- CMC support and supply chain quality
- Project and program management
Key Technologies
- Electronic regulatory submission platforms (eCTD)
- Clinical trial management systems (CTMS) and trial operations
- Pharmacokinetic and pharmacodynamic (PK/PD) analysis
- Pharmacovigilance and safety databases
News & Updates
PLC supported ARS with the EURneffy application and completed the submission and responses during the review process.
PLC supports the regulatory filings and clinical trials for various companies.
The company has supported multiple regulatory filings, clinical trial management, and product approvals for clients including Neurelis, ARS Pharmaceuticals, and others.
PLC directed the preparation and filing of the 510(k) application for Izun Pharmaceuticals, leading to FDA approval.
PLC supported ARS with the EURneffy application and completed the submission and responses during the review process.
PLC supports the regulatory filings and clinical trials for various companies.
The company has supported multiple regulatory filings, clinical trial management, and product approvals for clients including Neurelis, ARS Pharmaceuticals, and others.
PLC directed the preparation and filing of the 510(k) application for Izun Pharmaceuticals, leading to FDA approval.