MeLi LABS

Build Something That Can Withstand the Question:

"Where's the Evidence?"

I help biotech, pharmaceutical, and wellness companies build the scientific backbone their brand actually needs — not the one that looks good on a pitch deck.

I don't just consult for companies because it's a business model. I do it because every company that launches a health product without real science behind it makes the whole industry harder to trust.

Phisceuticals exists to raise the bar. When I work with a company, I'm not just helping them pass an audit or avoid a warning letter — I'm helping them become the kind of company that doesn't need to hide behind marketing language because their science actually holds up.

Whether you're building a compounding pharmacy, a peptide line, a supplement brand, or something that doesn't fit any existing category yet — I bring pharmaceutical-grade rigor and Phisceuticals-grade transparency.

Why I Do This Work

The MeLi MeThoDS 6-Phase Framework

Whether you're starting from scratch or auditing something already in motion, this framework maps every domain you need — in the order you need it.

  • Establish the corporate structure, legal protections, financial infrastructure, and insurance coverage that everything else builds on.

    This is where entity type, cap table, and board composition decisions either open or close future doors.

  • Recruit scientific leadership, build your R&D team, and establish the analytical methods, computational tools, and IP strategy that define your competitive edge.

    This phase sets the scientific foundation that regulators, investors, and partners will evaluate.

  • Secure your physical footprint — whether building, leasing, or sharing — and stand up procurement, equipment qualification, containment systems, and IT infrastructure.

    Every dollar spent here should trace back to a regulatory or operational requirement.

  • Implement your quality management system, stand up the QC laboratory, establish data integrity controls, and build the regulatory affairs function.

    This is where you prove to the FDA (and yourself) that your operation is audit-ready.

  • Move from discovery through preclinical work, lock down your CMC package, and launch clinical operations with CRO/CDMO partnerships.

    This is typically the longest and most capital-intensive phase — plan your burn rate accordingly.

  • Transition to GMP manufacturing, build your commercial and reimbursement teams, and launch marketing and science communications.

    The goal shifts from "can we make it?" to "can we sell it, sustain it, and scale it?"

Six domains where I provide direct, hands-on expertise — not general advice from someone who's never worked a lab bench:

  • Analytical Chemistry & Method Development
  • Containment & Hazard Protection 
  • Quality Control Laboratory
  • Data Integrity Program Design 
  • CMC Development
  • Marketing & Science Communication
Already have a company?

I run a diagnostic assessment — a structured gap analysis across all six phases with a prioritized remediation roadmap. Think of it as a health checkup for your company's science.

Starting from Scratch?

I build with you phase by phase, so you don't skip the steps that come back to haunt you when the FDA asks questions.

Not sure where your company stands?

If your product sits between pharmaceutical and holistic — peptides, functional foods, botanical therapeutics, or something entirely new — Phisceuticals may be the framework your brand has been missing. I help you develop products grounded in biochemistry that draw from every evidence-based tradition, without pretending any one tradition has all the answers.

Building something that doesn't fit the old categories?

The Simulator walks you through a guided assessment of your current phase, product type, and infrastructure — then shows you exactly which domains need attention.

[ Full results are available after a consultation ]

Engagement Pricing

Diagnostic Assessment: $15K–$35K — gap analysis + prioritized remediation roadmap

Targeted Phase: $40K–$70K — defined deliverable, clear scope and timeline

Retainer Advisory: Ongoing strategic and technical partnership

All projects are scoped individually to ensure alignment, integrity, and accuracy.

Let’s Talk About What You’re Building

Book a Call
Book a Call 
Or email directly: melissa.ms@melimethods.com