Regulatory Disclosure

Regulatory
disclosure.

BIOHACKER is a Swiss supplier of research-grade peptide compounds. We are not a pharmaceutical company. This document sets out, in plain language, what we are, what we are not, and the regulatory framework that applies to the catalogue.

Version III · 26.05 Effective 01 · 05 · 2026 Supersedes all prior versions

01What we are

BIOHACKER TEAM operates a chemistry-manufacturing facility in Lausanne under GMP-equivalent specification and ISO 9001:2015 certification. Our principal business is the synthesis, characterisation, and supply of research peptide compounds to qualified buyers.

02What we are not

We are not a pharmaceutical manufacturer. Our catalogue items are not registered with Swissmedic, the FDA, the EMA, the MHRA, the PMDA, or any other medicines regulator as therapeutic products. No statement on our site has been evaluated by any medicines regulator, and no item is approved to diagnose, treat, cure, or prevent any disease.

We are not a wellness brand, a dietary-supplement vendor, or a direct-to-consumer health service. We do not provide medical advice.

03Catalogue classification

The BIOHACKER catalogue is supplied for in-vitro laboratory research, qualified professional use, and approved partner distribution. Specific classifications by jurisdiction:

Switzerland — research chemicals; not a Heilmittel under HMG.
European Union — research chemicals; not authorised as a medicinal product under Directive 2001/83/EC.
United States — research chemicals; not approved by the FDA for human use.
United Kingdom — research chemicals; not authorised under the Human Medicines Regulations 2012.

Where a catalogue item is, in your jurisdiction, also separately scheduled as a prescription medicine, the Buyer is responsible for ensuring lawful use under that schedule.

04Restricted jurisdictions

We do not ship to jurisdictions where possession, distribution, or stated use of the catalogue is unlawful. The current list, reviewed quarterly:

Australia — SUSMP and TGA restrictions on peptide imports.
Brazil — ANVISA restrictions on imported research peptides.
China (PRC) — NMPA registration requirements for peptide imports.
Republic of Korea — MFDS restrictions.
Malaysia — NPRA registration requirements.

Where you are uncertain whether your jurisdiction permits the intended use, please consult the regulatory team before ordering.

05Quality and analytics

Every batch is characterised by HPLC-MS at our Lausanne facility and, where partner-volume requires, by an independent contract laboratory. Each unit ships with a unique Certificate of Analysis (COA) accessible via the COA portal. COAs are retained for ten (10) years.

06Anti-money-laundering & export controls

We are subject to Swiss AML obligations under the GwG and to EU and US dual-use export controls where applicable. Buyers may be asked, on a risk-based basis, to provide identity, beneficial-ownership, and intended-use documentation. We screen against the OFAC SDN, EU Consolidated, and SECO lists at order acceptance.

07Adverse events

Although our catalogue is supplied for research and qualified professional use, we operate a pharmacovigilance-style intake for any adverse event reported in connection with a catalogue item. Reports may be sent in confidence to safety@biohacker.team and are reviewed by our Medical Affairs lead within seventy-two (72) hours.

08Regulator contact

Regulators and competent authorities may write to regulatory@biohacker.team. We respond to authority requests in writing within ten (10) business days.

Issued by Regulatory Affairs · BIOHACKER TEAM
Zürich · 22 · 04 · 2026

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