Pharmaceutical Regulatory Strategies Tailored for Your Success
Our team provides comprehensive regulatory support for pharmaceutical companies, offering strategic and operational expertise to navigate complex regulatory landscapes across the US, EU, and beyond. From developing tailored regulatory strategies to preparing and submitting dossiers, engaging with health authorities, and managing post-approval lifecycles, we ensure every step of your regulatory journey is seamlessly executed.
Accelerated Review and Regulatory Pathways (BTD, PRIME, Fast-Track)
Assistance with Administrative Procedures (US Agent, SME)
Dossier Preparation and Submission (CTA/IND/MAA/NDA/BLA)
Health Authority Interactions (FDA/EMA/National Health Authorities)
Interactions with EU/US Health Authorities (FDA, EMA, National Competent Authorities etc.)
Marketing Application (MAA, NDA, BLA)
Participation in European Funding Programs for Innovative Products (i.e., Horizon Europe)
Post-Approval Lifecycle Management
Regulatory Strategy and Target Product Profile (TPP)
Special Procedures (Orphan, Pediatric, Expanded/Early Access Program)
Accelerated Review and Regulatory Pathways (BTD, PRIME, Fast-Track)
Assistance with Administrative Procedures (US Agent, SME)
Dossier Preparation and Submission (CTA/IND/MAA/NDA/BLA)
Health Authority Interactions (FDA/EMA/National Health Authorities)
Interactions with EU/US Health Authorities (FDA, EMA, National Competent Authorities etc.)
Marketing Application (MAA, NDA, BLA)
Participation in European Funding Programs for Innovative Products (i.e., Horizon Europe)
Post-Approval Lifecycle Management
Regulatory Strategy and Target Product Profile (TPP)
Special Procedures (Orphan, Pediatric, Expanded/Early Access Program)
