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Specialties
I am a protein analytical chemist who provides professional consulting and training in chemistry, manufacturing and controls (CMC) aspects of global biotechnology product development for regulatory filings and product approval. I also conduct due diligence and compliance audits of world-wide analytical laboratories for applicable quality practices (R&D, GLP and cGMP). Please refer to my business website [www.GlobalBiotechExperts.com] for detailed information on my activities, contact information, and informational links to relevant sites for regulatory guidances and biotech industry reference resources.