Frequently asked questions
Straight answers on what Lawsone sells, how dossier licensing works, what simulation can and cannot prove, and how a commission is scoped. Anything not covered here: aws@lawsone.si.
Questions / all of them
What is Lawsone?
A pharmaceutical R&D company that develops licensable formulation dossiers for marketed drugs. Each dossier contains a candidate master formula, manufacturing procedure, specifications, and equivalence evidence, validated in silico, licensed to generic pharmaceutical companies. Lawsone is based in Amman, Jordan, founded September 2026.
What is a development-ready generic dossier?
A package containing a candidate master formula (the quantitative recipe), a manufacturing procedure, specifications, and equivalence evidence. Enough for a licensee to run a first lab batch against a strong candidate instead of searching for one by trial and error. Full note.
Does Lawsone hold the innovator's proprietary formula?
No. Lawsone reconstructs candidate formulations from public regulatory records, labeling, excipient databases, patents, and laboratory evidence. What is delivered is a defensible point inside the equivalence region - not the innovator's confidential master batch record. How reconstruction works.
What does virtual bioequivalence prove?
It estimates whether a candidate's exposure should land inside the 80-125% bioequivalence window before a human study is run. It de-risks the batch decision; it does not replace the clinical bioequivalence study regulators require. Full note.
What is the f2 similarity factor?
A statistic comparing two dissolution profiles on a 0-100 scale. Regulators treat f2 of 50 or higher as similar. Lawsone dossiers target f2 ≥ 50 in all compendial media, not just one. Full note.
How does dossier licensing work?
Teaser first (non-confidential overview), then a mutual NDA revealing compound identity and the stage-1 data pack, then line-by-line diligence of the provenance map and evidence, then a territorial license on terms: upfront, milestones, profit share. The four steps.
Can a dossier be commissioned for a specific molecule?
Yes. Name the molecule, dosage form, and target markets and Lawsone scopes feasibility, timeline, and price before any commitment. Best fits: oral solids on conventional equipment, nanocrystal and amorphous-dispersion products, lipid and softgel fills, and reference products with hard-to-read formulations. Commission form.
What are provenance tags?
Every figure in a dossier is tagged verified (cited record), inferred (reasoned estimate, reasoning shown), or hypothesized (flagged for test). A diligence team can verify the file line by line instead of trusting a black box. The standard.
Which formulations does Lawsone cover?
Seven licensable assets today across oral solids, nanocrystal, amorphous solid dispersion, lipid softgel, hard capsule plus IV, and permeation-enhanced peptide classes. Compound identities are shared under NDA. The registry.
How do I contact Lawsone?
Write to aws@lawsone.si. Replies come from the dossier's author, usually within 48 hours.