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      <image:caption>MeLi MeThoDS is a scientific consulting firm bridging the gap between complex science and clear, actionable strategy. With 10+ years of pharmaceutical R&amp;D experience, IHC certification, and 97M+ products quality released, we serve biotech startups building their first product and wellness brands that want the science to back their story. Six core service areas: Analytical Chemistry, Containment and Hazard Protection, Quality Control, Data Integrity, CMC Development, and Science Communication. HPLC, ALCOA+, cGMP, FDA, ICH guidelines, OEL banding, process validation, Quality by Design, root cause analysis, formulation science, and regulatory compliance.</image:caption>
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      <image:caption>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-indicating method development, and system suitability troubleshooting. We shorten analytical timelines, advise on equipment and instrument purchases, and guide method transfer between sites. 10+ years of hands-on pharmaceutical R&amp;D experience with USP, spectroscopy, chromatographic separation, LOD/LOQ determination, and reference standard programs.</image:caption>
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      <image:caption>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 engineering controls evaluation. We design containment verification programs for potent compounds, advise on ventilation design and isolator technology, and ensure OSHA and ISO 14644 compliance. From wipe sampling to full occupational toxicology risk assessments, we protect your workers and your product.</image:caption>
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      <image:caption>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 investigation support, CAPA management, vendor qualification, environmental monitoring programs, and batch record review. From chain of custody to certificate of analysis, we help QC labs run leaner without cutting corners. Stability studies, release testing, deviation handling, change control, and trend analysis under one roof.</image:caption>
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      <image:caption>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 system validation (CSV), data migration planning, hybrid system remediation, or an access controls overhaul, we map your current state against regulatory expectations and close the gaps. Backed by direct experience with FDA warning letter remediation, risk assessment, and data lifecycle management across paper and electronic systems.</image:caption>
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      <image:caption>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) implementation. Services span process validation, scale-up, technology transfer, analytical comparability, stability programs, container closure integrity, and extractables/leachables assessment. From critical quality attributes to control strategy to raw material supply chain, we integrate your quality management system with your regulatory roadmap.</image:caption>
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      <image:title>Biotechnology - Solutions</image:title>
      <image:caption>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 clinical evidence into consumer-friendly language that holds up under scrutiny. Services include structure/function claims guidance, MoCRA compliance, certificate of analysis review, third-party testing strategy, ingredient sourcing transparency, and marketing copy review. Your science should be as strong as your story.</image:caption>
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