Industries
Built for regulated products.
Every industry has its own pathways, documentation and evidence expectations. We work across five to start.
01
Pharmaceuticals
Market entry, registrations, CMC, submissions, lifecycle and regulated manufacturing support.
View services- Market authorisation strategy
- CMC and dossier support
- Variations and renewals
- Regulated manufacturing partners
02
Medical Devices
Classification, technical documentation, market entry and ongoing compliance.
View services- Classification and pathway
- Technical documentation
- Authorised representation
- Post-market compliance
03
HealthTech & SaMD
Regulatory pathways for software, digital health and AI-enabled medical products.
View services- Software classification
- AI-enabled product pathways
- Clinical evidence planning
- Quality management alignment
04
Cosmetics
Product compliance, labelling, safety documentation and international market entry.
View services- Product information files
- Labelling and claims review
- Safety documentation
- Responsible person services
- Registration and notification
- Safety data documentation
- Import and export compliance
- Cross-border market access