Our Areas of Expertise

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

Import & Export
- Provide assistance to complete Export Health Certificates
- Provide assistance to complete Private Attestations
- Provide assistance to complete Support Attestations

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

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

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

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

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
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
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

Food

Medicines

Cosmetics

Medical Devices
