At Althian, we offer a comprehensive range of Regulatory Affairs services to ensure compliance and success in the complex landscape of pharmaceutical and medical device regulations.
Our experienced team is committed to delivering high-quality regulatory solutions tailored to meet your specific needs. Contact us today to learn more about how we can help navigate the regulatory landscape and achieve regulatory compliance efficiently.
1. Regulatory Strategy & Consulting
2. Regulatory Intelligence & Gap Analysis
3. Dossier Preparation & Submission (CTD/eCTD)
4. Product Registration & Marketing Authorization
5. Clinical Trial Applications (CTA) & Approvals
6. Regulatory Liaison & Health Authority Interactions
7. Labeling & Packaging Compliance
8. Pharmacovigilance Regulatory Support
9. Post-Approval Life Cycle Management
10. Regulatory Translation & Localization
11. Import, Export & Customs Regulatory Support
12. GMP & Regulatory Inspections Support
13. Device & Combination Product Registration
14. Regulatory Training & Workshops
