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.

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  • Market authorisation strategy
  • CMC and dossier support
  • Variations and renewals
  • Regulated manufacturing partners
02

Medical Devices

Classification, technical documentation, market entry and ongoing compliance.

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  • Classification and pathway
  • Technical documentation
  • Authorised representation
  • Post-market compliance
03

HealthTech & SaMD

Regulatory pathways for software, digital health and AI-enabled medical products.

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  • Software classification
  • AI-enabled product pathways
  • Clinical evidence planning
  • Quality management alignment
04

Cosmetics

Product compliance, labelling, safety documentation and international market entry.

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  • Product information files
  • Labelling and claims review
  • Safety documentation
  • Responsible person services
05

Chemicals

Regulatory compliance, documentation and cross-border market access.

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  • Registration and notification
  • Safety data documentation
  • Import and export compliance
  • Cross-border market access