Castillo Pharma Consulting
…your CMC expert for Radiopharmaceuticals and beyond
Services
Drug Development
- Project Management
- CDMO Management
- R&D strategic support
- IP strategic support (in cooperation with legal partners)
- Audits according to cGMP (in cooperation with external partners)
Regulatory
- IMPD & IND module 3 drafting for Clinical Phase I to III Studies
- CMC Briefing Book Drafting/review for Scientific Advice processes (eg. for EMA or FDA)
- Review of CMC related pharmaceutical regulation
Supply Chain
- Operational Supply Chain support. (including production, storage, and distribution of Drug Substance and Drug Product, and on-site radiolabeling for short lived radiopharmaceuticals)
About me (Juan Castillo, PhD.)
A chemist by education, I already started specializing in radiochemistry and radiopharmaceuticals during my Masters and PhD Studies. I have 15 years of experience as a radiopharmaceutical chemist, as well as 5 years of experience as CMC manager and director.
My fields of expertise include diagnostic and therapeutic radiopharmaceuticals, peptide and small molecule production, Drug Substance and Drug Product production and documentation, (including IMPDs and IND Modules 3), drafting of Briefing Books for Scientific Advices (EMA, FDA), preclinical research, radiopharmaceutical R&D, CMC relevant regulatory laws and regulations, and IP/Patent Management, radiopharmaceutical supply chain management for clinical studies.
Career:
- Bachelor of Sciences at FU Berlin (Chemistry)
- Master of Sciences at FU Berlin (Chemistry)
- PhD at FU Berlin (Radiochemistry)
- Radiochemist at Charité Berlin Campus Virchow Klinikum
- Postdoctoral Researcher at TU Eindhoven / University Hospital Colonge
- (Senior) CMC Manager at Pentixapharm AG (formerly PentixaPharm GmbH)
- CMC Director at Pentixapharm AG
Email: juan@castillo-pharma.com
