Quality & Compliance

Compliance is the operating system

Altanova's quality and compliance framework is organised around three core regulatory areas.

GMP & batch release

EU-GMP-anchored release architecture

Altanova is establishing a Swissmedic-aligned sourcing and release framework under EU GMP standards. Swiss GMP inspections are recognised by the European Union under the EU–Switzerland Mutual Recognition Agreement. Batch release will be performed through qualified Swiss and EU GMP partners under Altanova's quality architecture.

Citation: Art. 5–7 AMBV · EU-CH MRA

Narcotics handling

Art. 4 BetmG framework.

The manufacture, distribution and dispensing of controlled substances in Switzerland is governed by the Federal Act on Narcotic Drugs and Psychotropic Substances (BetmG) and the Narcotics Control Ordinance (BetmKV). Where a therapeutic franchise handles controlled products, that framework confines all activity to the regulated medical channel; Altanova's standing policy is strict separation from any non-medical market.

Citation: Art. 4 BetmG · BetmKV

Safety reporting

ElViS-aligned reporting.

Healthcare professionals and patients are asked to report any suspected adverse reactions through the routes described on our Safety reporting page, or directly to Swissmedic through the ElViS electronic vigilance system. Social-media channels are not a forum for adverse-event reporting.

Citation: Art. 59 HMG · Swissmedic ElViS

Supply chain integrity

Controlled product identity, from source to pharmacy counter

Qualified source

Active pharmaceutical ingredients and excipients are sourced from qualified suppliers and assessed against defined product and quality requirements. For botanical materials, supplier qualification also considers applicable cultivation and collection standards.

Testing & release

Testing is designed around European Pharmacopoeia methods, with Swiss technical release performed through qualified partners. The full testing panel, including franchise-specific requirements, is defined per product specification.

Controlled logistics

Distribution is designed for temperature-controlled, tamper-evident handling with full chain-of-custody documentation, through wholesalers operating under EU-GDP and national narcotics authorisations.

Safety reporting

Report a suspected side effect

Healthcare professionals and patients can report suspected adverse reactions through Altanova's dedicated reporting channel.

Report a suspected side effect