Regulatory Affairs and Market Access
Navigate Regulatory Pathways with Confidence
Our Regulatory Affairs and Market Access services are designed to help you navigate complex regulatory landscapes and achieve timely product approvals. From regulatory strategy development to post-approval support, we provide end-to-end solutions tailored to your business needs.
Our Services Include:
Regulatory Strategy Development:
Customized regulatory strategies aligned with market-specific requirements.
Representation at regulatory agency meetings to streamline approvals.
Regulatory Submissions:
Comprehensive preparation and submission of dossiers for drugs, biologics, and medical devices.
Ongoing management of regulatory interactions and submissions.
Post-Approval Activities:
Monitoring post-marketing safety and managing label changes.
Preparing periodic safety update reports (PSURs).
Market Access:
Health technology assessments (HTAs), pricing strategies, and reimbursement negotiations.
Patient access programs and market launch planning.
Regulatory Compliance:
Conducting gap analyses and remediation.
Internal audits and inspection readiness support.
Why Choose Us?
Our global expertise ensures that your products meet regulatory requirements efficiently, enabling faster market access and sustained success.
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.
