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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: [email protected]

Type: Service / Capability Showcase

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

Hashtags: #cmc, #knowledgefromexperience, #weareasphalion