Technology Incubation & Development

1. Innovation & Strategy

  • Concept validation
  • Compound discovery & development
  • Product innovation
  • Product development
  • Product formulation optimization
  • Laboratory services
  • Commercialization Readiness
    • Medical marketing
    • Strategic brand management

 

2. Research & Clinical Services

  • Pre-clinical research validation & trial coordination
  • Clinical research validation & trial coordination

 

3. IP strategy & prosecution

  • Patent portfolio strategy
  • Patent drafting, filing & prosecution
  • Data to IP asset
  • Patentability & FTO assessment

4. Regulatory Affairs (Food, dietary supplements, medical devices, FSMPs, botanical drugs)

  • Regulatory compliance & strategy
    • Regulatory gap analysis
    • Advice on pptimal regulatory route to enter EU and US markets
    • Label check for compliance
  • Application & submission to regulatory agencies for registration/certification for medical devices and supplements
    • EFSA health claim applications
    • Novel food applications (incl. safety & benefit evaluations)
  • EFSA safety evaluation for fermentation processes & plant-based proteins
  • Traditional herbal medicines for EU, including Germany, Austria and Switzerland
  • Natural Products: Botanical extracts from tropical biodiversity for local & US markets, value added food products (drinks) from tropical fruits from cultivation to production 

5. Total Quality, QMS

  • Total quality & Quality Management System
  • QMS documentation (i.e QM, SOP, Forms templates) with regular updates
  • Internal quality audit, QMS document audit/review, pre-certification audit and suppliers audit
  • Pharmacovigilance and product/medical enquiry handling
  • Quality gap analysis & strategy
  • Preparation of product dossiers for medical devices and supplements
  • Risk management file & report generation,
  • Post-market surveillance plan & report generation, 
  • Supplier quality management (audit, performance monitoring)

 

6. Manufacturing & Supply Chain

  • Manufacturing & production optimization
  • Legal manufacturer service (for supplements, medical devices)
  • End-to-end supply chain and quality management
  • Specialty extraction
  • Pilot/small scale manufacturing