Andreas Bockler
Germany
CMC GMP Analytical Sciences Quality Control HPLC GC Method development Development CDMO CRO Nanomedicine Nano API Drug Substance Drug product Formulation Development ATMP
About
Experienced CMC and GMP consultant with a strong background in analytical method development, quality control, and validation for complex modalities (Nanomedicines), including oligonucleotides, LNPs and other advanced therapeutics (ATMP). Proven track record supporting biotech and CDMO environments through development of robust IP-RP-HPLC/UPLC/MS methods, impurity profiling, characterization strategies, tech transfer, and preparation of regulatory-compliant documentation (ICH, EMA, FDA). Skilled in establishing phase-appropriate CMC strategies, optimizing laboratory workflows, implementing GMP-compliant QC systems, and supporting early- to late-stage development programs. More info at www.boecklers.com
Experience
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