CMC Pharma Consulting - CMC & More GmbH

We support Pharma, Biotech, and Medtech organizations in preparing for regulatory submissions, offering strategic, hands-on guidance across the full spectrum of 💥CMC development. From early-stage planning to regulatory dossier preparation, we help you build a solid foundation for 🎯clinical success - efficiently, compliantly, and with care 🤝. 🚀 Our Mission We deliver time- and cost-effective CMC development — putting the right amount of effort at the right time. CMC & More helps you move your development forward toward your next approval — efficiently, compliantly, and with care. ⚠️ Why Engage a CMC Expert Early? 🎯 Avoid delays, wasted investment, and rework. Involving a CMC expert at an early stage allows you to: - Tap into cross-functional CMC knowledge - Anticipate future challenges 💥 - Maintain quality and regulatory compliance - Align phase-dependent investments with project needs 🌟 Why CMC & More? 🎯 Expertise that truly cares — about your project success and stakeholder satisfaction - Hands-on drug development experience, backed by strategic insight - Tailored support — high-value, personalized, and cost-conscious 💥 - Streamlined collaboration — no admin burden, one single point of contact 🔧 Our Services 🏭 Manufacturing: Drug Substance & Drug Product - Strategic CMC development planning 💥 - Supplier selection & qualification - Vendor management - Formulation & analytical development - Process development & scale-up - GMP manufacturing coordination - Process & method validation 🧬 Regulatory & QA Compliance - QA compliance: from non-GMP to GMP transitions 💥 - Regulatory compliance strategy (EMA, FDA) - Preparation and writing of CMC dossiers (CTA/IND, MAA/NDA) 🩺 Clinical Supply - Clinical supply planning (demand, production, IRT setup) - Packaging & labeling support 💥 🧭 & More - Agile project management - Interim leadership and technical team support 💥 🔗 Visit us: www.cmcandmore.com 📧 Get in touch: fuegadvisory@cmcandmore.com