Our Areas of Expertise

Regulatory Services

  • New product registrations (product licences, ASMFs) from conception to grant.
  • eCTD validation and submission
  • Readability studies
  • Lifecycle management activities - variations and notifications
  • Regulatory strategy: maximising regulatory opportunities of existing portfolio and product
  • Regulatory compliance from gap assessment to remediation
  • Export market registrations in local language

Quality Assurance

  • UK/EU QP & RP services
  • Internal & external auditing (GMP/BRC/ISO/GDP)
  • Management of quality improvement projects
  • EU/UK batch release
  • Quality assurance and QC support
  • Risk assessment and management

Marketing & Label Checking

  • Advertising & marketing material compliance
  • Label checking and compliance
  • Digital asset compliance
  • Social media compliance
  • Broadcast compliance in all regulatory categories

Pharmacovigilance Service

  • UK QPPV and national contact person services
  • Quality systems to fulfil Pharmacovigilance obligations
  • Pharmacovigilance system master file (PSMF) preparation
  • Collation, assessment, follow-up and electronic reporting of ICSRs
  • Periodic safety update report (PSUR) authoring
  • Risk management plans and implementation of risk minimisation measures

Nutravigilance

  • Contact person for nutravigilance
  • Handling of customer complaints
  • Review, assessment and follow-up of adverse events
  • Event reporting to authorities
  • Safety impact assessments
  • Risk management plans

EU FBO Services

  • Labelling advice
  • Regulatory compliance checks
  • Compilation of technical dossiers
  • Supply EU address
  • Brexit advice
  • Nutravigilance services
  • Batch release and support
  • EU notifications and registrations

Medical Devices & IVDs

  • MDD and MDR compliance
  • CE marking assistance
  • Authoring compliant technical documentation
  • EU authorised representative services
  • UK responsible person services
  • Product lifecycle management

Import & Export

  • Provide assistance to complete Export Health Certificates
  • Provide assistance to complete Private Attestations
  • Provide assistance to complete Support Attestations

Additional Services

  • EU/UK RP services cosmetics
  • Quality management services
  • ECTD publishing medicines
  • Cosmetic products dossier (PIF)
  • Biocide regulations
  • Regulatory intelligence
  • Trade marking
  • Formulation & development
  • Speak to us about our automated compliance tool

We provide support for

Food Supplements

Medicines

Cosmetics

Medical Devices

Food

Biocides

UK OFFICE

  • 5 Maritime House,

    Maritime Business Park, Livingstone Road, Hessle, HU13 0EG
  • +44 1482 702726
  • info@rubicontechnical.co.uk

NL OFFICE

  • Keizersgracht 555,

    1017 DR Amsterdam, Netherlands
  • +31 (0)20 3085473
  • regulatory@rubicontechnical.nl

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