We understand that the healthcare industry is global, and regulatory requirements vary significantly from one country to another. Our Regulatory Affairs team is well-versed in the regulatory guidelines of multiple countries, ensuring that we can provide comprehensive support to our clients in various international markets.
Lifecycle Management & Post-Market Compliance
Our support continues after product approval, ensuring compliance throughout the product’s lifecycle.
- Post-Approval Changes & Variations: We assist with regulatory requirements for changes in product formulation, manufacturing processes, or labelling.
- Pharmacovigilance & Drug Safety: Our team helps implement pharmacovigilance systems for monitoring and reporting adverse events, ensuring ongoing compliance with safety regulations.
Regulatory Submissions and Documentation
We specialize in the preparation and submission of regulatory dossiers and other essential documents, ensuring accurate, timely, and compliant filings.
- Regulatory Dossiers & Filing Support: Our experts ensure the timely preparation of regulatory dossiers, including chemistry, manufacturing, clinical, and labelling sections, tailored to each regulatory agency’s requirements.
Expedited Review Pathways: We assist with navigating fast-track approvals, breakthrough therapy designations, and priority reviews to expedite market access for urgent medical products.