Alessio J. M. Rossini — Scientific Consulting

Capabilities

Four lanes. Engagements usually cross two of them, because a molecular question rarely stays molecular once a production line is involved.

Area	What I deliver	Usual format
Molecular design & preclinical reasoning
Drug design	QSAR, CoMFA and in-silico assessment of a scaffold or analogue series; what the structure predicts and where the prediction stops being trustworthy.	Written assessment
Structure–activity interpretation	Reading an analogue series for target engagement, selectivity and the liabilities that travel with a substituent.	Written assessment
Pharmacodynamics & pharmacokinetics	Receptor profile, mechanism, ADME reasoning, and the interaction surface a compound brings with it.	Written assessment or review call
Formulation & manufacturing
Dosage-form design	Capsules, modified-release and injectable forms: excipient rationale, release behaviour, stability exposure.	Design document
Active ingredients	API specification, supplier documentation review, identity and purity criteria, and what a certificate of analysis does not tell you.	Specification & review memo
Production line design	GMP-compliant line and process layout, from unit operations to the flows and segregation the standard expects.	Design document
Sourcing & import
China → EU supply	Sourcing routes, supplier qualification, documentation and import pathway for raw materials and actives.	Advisory, per shipment or per programme
Evidence & claims
Claim auditing	Every claim on a product or in a dossier traced to its primary source, graded by evidence level, with the unsupported ones named. Superlatives get attacked separately from the facts they sit on: the fact usually survives, the superlative often does not.	Audit memo, claim by claim
Performance & cognition pharmacology	Nootropics and performance compounds: mechanism, evidence grading, and the rationale (or absence of one) behind a combination.	Written assessment or training session
Literature & competitive reading	What the field actually published this quarter, separated from what was announced about it.	Briefing, one-off or recurring

Selected engagements

Clients, products and programme names are withheld by agreement. What is described is the work and what it concluded.

Case 01 · 2026 · oral dosage form · excipient platform design

A platform promising seven functions, resolved into the four a dry blend can actually deliver.

Brief: Establish what a pre-engineered dry excipient system would have to contain, how it would have to be optimised, and what would have to be measured, for its technical sheet to be defensible.
Work: Each claimed property was resolved into the physical quantity that must change, the parameter that detects it, a proposed acceptance target, and the evidence tier at which the claim becomes sayable. Candidate excipients were compared on function rather than familiarity, and two widely used ones were excluded on liabilities that surface only with particular compound classes.
Outcome: The seven functions were shown to be two opposing problems, not one: four are bulk powder mechanics, three are interfacial and thermodynamic, and they pull against each other, so no single fixed composition sits at the optimum of all. The recommendation was a modular architecture — a fixed manufacturing core plus a delivery module selected per compound class. And a ceiling was stated plainly: no dry blend raises equilibrium solubility, so the bioavailability claim was placed outside the formulation-evidence envelope and routed to a pharmacokinetic study. The headline claim was not deliverable by the product that had been asked for, and the dossier says so on its second page.

Case 02 · 2026 · consumer health · US market entry, concept and regulatory strategy

Three of the brief’s own premises were wrong. Correcting them first is what left a legal product.

Brief: Determine whether a fast-acting, mechanistically distinct product could be built, manufactured and sold in the United States without becoming either a commodity or an unapproved drug.
Work: Every pharmacological statement was tagged by evidence class — controlled human trial, human mechanistic, weak human, animal, in vitro, none — with an explicit rule for what each class licenses in commercial and investor material. Regulatory positions were verified against the statute, the agency’s ingredient directory, its notification database and named warning letters; pharmacology against retrieved primary records. Figures that could not be traced to a primary source were flagged as unverified rather than repeated.
Outcome: The delivery route in the brief was statutorily unavailable; a second route was unavailable as a claim, which is a labelling constraint rather than a formulation one; and the intended doses exceeded the format by one to two orders of magnitude. The most attractive mechanism in the file was also dropped — the controlled experiment behind it had succeeded on a different variable from the one the product idea rested on. What survived those corrections was a defensible position; what did not was documented as inspiration, not formula.

Case 03 · Commercial client, Europe · small-molecule manufacture

A synthetic route carried from the bench to a campaign measured in tens of kilograms.

Brief: Take a small molecule that worked at laboratory scale and establish whether it could be made in quantity, then plan how.
Work: Synthetic route design, reaction setup and execution, work-up and purification, and a scale-up assessment: material balances, reactor sizing, equipment selection, sterile and single-use filtration, manufacturing flow, and the CAPEX and OPEX that follow from those choices.
Outcome: Route and process plan taken into production. As part of the manufacturing team, the campaign reached approximately 30 kg of final isolated product.

Case 04 · Commercial client · EU–China supply chain

Separating manufacturers who can actually make the material from traders who cannot.

Brief: Qualify suppliers for actives, precursors and process equipment, where the quotations all look equally credible on paper.
Work: A supplier-assessment method built on four signals that are hard to fake: technical responsiveness to specific questions, the quality of the documentation offered unprompted, evidence of the equipment the process actually requires, and commercial behaviour under pressure. Applied across European and Chinese manufacturers, informed by operational time in Shenzhen.
Outcome: A qualification procedure that distinguishes demonstrated manufacturing capability from trading and marketing claims, with the technical documentation review to support it.

How an engagement runs

Scoping call, 30 to 60 minutes. You describe the problem; I tell you whether it is one I should take, and what answering it would require. If it is outside what I do, I say so on that call.
Written scope. Question, deliverable, timeline and fee, fixed before any work starts. No open-ended retainers unless you want one.
The work, and the deliverable in writing. Every conclusion carries its evidence level and its source. Where the data does not support a conclusion, the deliverable says that instead of filling the gap.
Review. A call to walk through the deliverable with your team, and one round of follow-up questions included.

Working language: English or Italian. Remote by default; on site in Switzerland and northern Italy where a line or a lab actually has to be seen.

Background

Organic chemist, pharmacologist and drug designer. Sciences Pharmaceutiques at the École de Pharmacie Genève–Lausanne, a five-year programme completed in 2017, followed by postgraduate work in drug design and new psychoactive substances at the University of Pavia. Independent practice from Lugano since 2017, across molecular design, formulation and manufacturing.

Since 2013 I have also been an external scientific consultant to the European drugs agency — EMCDDA, now EUDA — and to the CFSRE, on the early identification and technical profiling of compounds emerging on the international market, including the first signals of the synthetic opioids.

Discipline: Organic chemistry · pharmacology
Training: EPGL Genève–Lausanne · Univ. of Pavia
Independent since: 2017
Based in: Lugano, Switzerland
Analysis: HPLC · LC-MS · GC-MS · TLC · ¹H NMR
Engagement: Independent, direct — no intermediaries

What I am not

Stated up front, because a consultant who is vague about scope costs more than one who is narrow about it.

Not a physician. I do not diagnose, prescribe or treat. What you get is the reading of a pharmacologist and drug designer.
Not a CRO or a laboratory. I do not run the assays. I design what should be run, and I interpret what came back.
Not a regulatory affairs firm. I do not file your dossier. I make sure the science inside it holds before someone else reads it.
Not a source of favourable conclusions. If the data does not support the claim you need, the deliverable will say so. That is the service.

Contact

Direct

alechemist_info@pm.me

For a scoping call, book a slot directly. Tell me the sector and the question in one paragraph; that is enough for me to prepare.

Book a scoping call

Or write from here

Professional notice. Alessio Rossini is not a medical doctor and does not substitute for one. Consulting output is scientific and technical advice; it is not medical advice, diagnosis or treatment, and it does not constitute regulatory certification. Responsibility for commercial, clinical and regulatory decisions remains with the client.