The mission of Pacific-Link Consulting is to provide our customers with a superior quality of service that is both cost effective and customized to each clients’ needs in order to maximize their potential for success. We strive to add value by contributing to the development of novel medical technologies, while protecting the integrity of our client and safety of patients in clinical trials.

Our mission is further enhanced by providing timely, concise services that range from business development, product development, regulatory affairs, clinical trials, medical writing and more. We provide services for the United States, European, Japanese and Canadian markets. Our experts understand the ever changing laws and regulations of these markets and guide our clients through the process as effectively and advantageously as possible.

We’ve assisted clients with New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDAs), Pre-Market Authorizations (PMA), Investigational New Drug (IND), Orphan Drug Designation, PMDA Consultation, Medical Monitoring, Safety Management, Japanese Orphan Designation, Japan Clinical Trial Notification (CTN), FDA interactions, early phase and late stage clinical trials management, Clinical Trial Applications (CTAs) In Canada, New Drug Submissions (NDS) in Canada, Medical and Technical Writing, Medical Affairs Review, Post Marketing promotional as well as Postmarketing Pharmacovigilance.

Learn more about our various services:
Regulatory Services – US and EU
Regulatory Services – Japan
Clinical Trials
Product Development Support
Business Development