Asphalion: Your Regulatory Compass in Pharma

At Asphalion we offer Streamlined Compliance & Efficiency in CMC Services.

Asphalion delivers comprehensive CMC services, enhancing regulatory pathways from early development to post-approval. With over 70 IMPDs, 35+ INDs, and 60+ EU Scientific Advice procedures in 5 years, we're a beacon of regulatory excellence.

Our services include:

• Tailored EU/US regulatory strategies.
• Thorough gap analysis and Due Diligence.
• Lifecycle management consultancy.
• Prompt response to regulatory inquiries.

Specializing in Quality by Design, we ensure GMP compliance and quality across product development.

At Asphalion we ensure swift compliance and market entry. We navigate the regulatory maze so you can reach your goals with precision and speed.

Visit our website or contact us at: [email protected] to explore how we can accelerate your regulatory success.