MeLi MeThoDS is a scientific consulting firm bridging the gap between complex science and clear, actionable strategy. With 10+ years of pharmaceutical R&D experience, IHC certification, and 97M+ products quality released, we serve biotech startups bu
Analytical Chemistry and Method Development consulting for pharmaceutical and biotech companies. Services include HPLC and GC-MS method validation, ICH Q2(R2) compliance, instrument qualification (IQ/OQ/PQ), forced degradation studies, stability-indi
Containment and Hazard Protection consulting for pharmaceutical manufacturing and laboratory environments. Industrial Hygiene Chemist (IHC) providing OEL/OEB banding, exposure assessment, air and surface sampling, HEPA filtration review, and engineer
Quality Control Laboratory consulting for cGMP pharmaceutical and biotech operations. We streamline sample management, optimize lab scheduling, and build SOPs that actually get followed. Services include FDA 21 CFR compliance, LIMS integration, OOS i
Data Integrity Program Design for GxP-regulated environments. We build ALCOA+ compliant data governance programs from the ground up, addressing 21 CFR Part 11, EU Annex 11, electronic records, audit trails, and metadata standards. Whether you need sy
Chemistry, Manufacturing, and Controls (CMC) Development consulting for drug substance and drug product programs. We support ICH Q8 through Q12 compliance, CTD Module 3 preparation, IND/NDA regulatory filing strategy, and Quality by Design (QbD) impl
Marketing and Science Communication consulting for wellness brands, supplement companies, and health product founders. We review label claims for FTC and FDA compliance, build substantiation dossiers from peer-reviewed research, and translate clinica