Regulatory, Scientific & Safety Consulting in Life Sciences
Asphalion’s CMC Services: Accelerating Compliance
Scope: Offering full-spectrum CMC services for swift regulatory navigation from early development to market.
Achievements: Expertise in 70+ IMPDs, 35+ INDs, and 60+ Scientific Advice procedures with EU bodies.
Services:
• Strategic regulatory guidance for EU/US.
• Gap analysis and Due Diligence.
• Lifecycle management and post-approval changes.
Expertise: Focused on Quality by Design and GMP to ensure top-tier product quality.
Partner with Asphalion for efficient regulatory compliance and market success.
Contact us for details: info@asphalion.com
Category:
CMC: Biologics, Drug Substance CMC: Biologics, Drug Product CMC: Biologics, Analytical CMC: Biologics, Drug Delivery CMC: Small Molecules, Drug Substance CMC: Small Molecules, Drug Product CMC: Small Molecules, Analytical CMC: Small Molecules, Drug Delivery Discovery: Target Discovery Discovery: Discovery Chemistry Discovery: Discovery Biology Discovery: DMPK