Regulatory Services

Menu
Navigating Complex Regulatory Landscapes
Trust our comprehensive regulatory services to ensure compliance and streamline your product registration process.
Contact Us

Data Analytics & Regulatory Intelligence

Pre-submission Strategy

Pharmacovigilance Management

Authority Engagement, New Registration & Marketing Authorisation Transfer Application

Post-Approval Changes & Maintenance

Market Entry Strategy Consultation

Our high adaptability teams collaborate with local authorities to introduce novel products through strategic registration pathways for rapid market entry.

Dossier Preparation & Registration Submission

We have experienced teams with more than 3,000 new registration and marketing authorisation transfer approvals.

Regulation Changes Impact Assessment

We establish a process to anticipate impact of new regulations change for transition planning with minimal disruption to business.

Regulatory Commercial Supply Coordination

We ensure dedicated project managers liaising regulatory readiness on product launch, mapping post-approval changes to supply schedule, and more, to ensure market compliance.
News | Insights