What We Will Not Make
Stating the limits in advance saves everyone time. Vegalab is a delivery technology and formulation partner, and there are categories of work we decline regardless of budget.
Categories we decline
We do not formulate unapproved compounds into products intended for human consumption or administration. We do not supply peptides, drugs or research chemicals, and we will not act as a link in a chain that resells research-grade material for human use. We do not write dosing schedules, reconstitution instructions, cycles or administration protocols, and we do not produce products designed to circumvent anti-doping rules or import controls. We decline work where the claim a partner intends to make is not supported by evidence for the finished product in the intended market.
Why the line sits there
Two reasons, both commercial. First, our manufacturing and quality position depends on GMP standing and clean regulatory relationships across several jurisdictions, and a single unapproved-use project puts that at risk for every other partner on the line. Second, encapsulation cannot fix a compound whose problem is the absence of human safety data. A delivery improvement applied to an untested molecule increases exposure to an unknown, which is the wrong direction of travel.
What we ask before a scope
Five questions. What is the compound and its documented provenance? What is the target market and product classification? What claim will the finished product make, and what evidence supports it? Who holds the regulatory standing, the sponsor or the brand? And what studies is the partner prepared to fund, since a feasibility result without a pharmacokinetic or stability program rarely leads anywhere. Clear answers usually mean a fast start. We also ask what happens if a study result is negative, because a partner who cannot accept that answer is buying reassurance rather than development work, and that is a poor basis for a program.
What we will do
We take on approved-molecule reformulation with a defined regulatory path, supplement and natural health product development against a monograph or a submission, cosmetic and professional formats, veterinary formats where the regulatory path is clear, and preclinical research support for qualified sponsors. Those are the projects the platform was built for. Veterinary formats, professional cosmetic formats and shared payloads with Beauty Science are all in scope. If a project fits one of those descriptions, the fastest route is a one-page summary of payload, market and claim rather than a general inquiry.
Key facts
- Distributing an unapproved new drug intended for human use is prohibited in the US (21 U.S.C. 331, 355)
- Human administration of an investigational compound requires an authorized trial application and ethics approval (21 CFR 312; EU Regulation 536/2014)
- A supplement bearing a disease treatment or prevention claim becomes an unapproved drug (21 U.S.C. 321(g); 21 CFR 101.93)
- GMP controls cover the whole facility, including equipment, cleaning and cross-contamination, so one product's practices can affect others made at the same site (ICH Q7; PIC/S GMP Guide)
How our delivery technology applies
Our platform is a manufacturing asset before it is a marketing story. Multi-layer encapsulation under GMP only holds value if the line stays auditable, which is why project selection is part of the technology offer rather than a legal afterthought. Partners get a delivery system with documented composition, batch records and stability data that a regulator can read.
If your project fits the second list, send the five answers and we will scope it.
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