Sevilito CMC Biotech

Meet Tore Søderblom: Your CMC Navigator

Principal Consultant and Company Owner

Profile

With 30 years of experience in biopharmaceutical development and production, Tore brings a rare combination of scientific depth, regulatory expertise, and operational leadership. Tore has successfully managed CMC development from early-stage research through commercial launch, including GMP production, regulatory filings (IND, CTA, BLA, MAA), process validation, and QA compliance.

Key Strengths

• Proven ability to keep a steady hand during project turbulence and change.
• Senior management experience across biotech and pharma, including VP, Director and Senior Manager roles at Y-mAbs Pharmaceuticals, Novo Nordisk, and AGC Biologics.
• Deep knowledge of CMC for biologics, conjugated products, and radiopharmaceuticals.
• Extensive stakeholder management and cross-cultural negotiation expertise.
• Track record of successful regulatory submissions in the US, EU, and globally (Owner/responsible for 9 IND/CTA and 2 market applications).

Why Tore?

Tore’s unique blend of technical, regulatory, and leadership skills ensures biotech startups have a partner who can guide them through complexity, keep projects on track, and deliver results - no matter how challenging the journey.

Contact Tore