• Regulatory Solutions
• Market Intelligence
• Supply Chain Management and Technical Services
• Orphan Drug Management

MANAGING REGIONAL COMPLEXITIES, ENSURING LOCAL COMPLIANCE

Countries in Asia Pacific differ in regulatory requirements and are at different stages of
regulatory development.

Our highly trained and experienced regulatory personnel can ease your burden of dealing with such complexities. We offer a strategic and integrated registration plan for the region and coordinate implementation of registration efforts through one channel.

PROFESSIONAL AND RESULTS-ORIENTED TEAM

Our regional and local regulatory management provide tailor-made solutions for your needs. We offer a wide spectrum of regulatory activities to facilitate your product's smooth market entry into this complex region.

Our business partners often benefit from our regulatory strategies that lead to fast product registration and swift market entry in a cost-effective manner.

We also manage post-marketing obligations and continued regulatory compliance such as pharmacovigilance, adverse event reporting, post-marketing studies, named patient basis applications and other compliance requirements.

ESTABLISHED SYSTEMS AND PROCESSES

We follow a strict methodological approach in executing regulatory filings by ensuring full transparency at each step of the regulatory process.

With more than 2,000 products currently registered and maintained by PharmaLink, our expertise makes us your ideal partner for regional registration of new pharmaceutical products and penetration of Asia Pacific markets. Also, the proven performance of our regulatory teams across the region has led to an increasing number of clients seeking our services.