Our Areas of Expertise

GPSR
- GPSR Compliance
- EU RP Services
- Authoring Compliant Technical Documentation
- Technical Documentation Gap Analysis
- Labelling Advice/Assessments
- Regulatory Advice
- Product Safety Risk Assessment Support

RP Services
- Supply of UK/EU address
- Ownership of responsibility of the product in market
- Regulatory Compliance Checks
- Quality Compliance checks
- Vigilance Services
- Notifications & Registrations
- Batch Release
- Liason with Competent authorities
- Market Surveillance
- Product Withdrawal / Recall Support

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

Animal Feed
- Formulation & Label Reviews
- Confirming Ingredient Registration
- Complete Pet Food & Animal Feed Compliance
- Complementary Pet Food & Animal Feed Requirements
- Additives checking
- Regulatory advice

Cosmetics
- Formulation Assessments
- CPSR Authoring
- Cosmetic Products Dossier (PIF)
- Cosmetovigilance
- Artwork/Labelling Assessments
- Regulatory advice
- EU/UK RP Services
Additional Services
- EU/UK RP services cosmetics
- Quality management services
- ECTD publishing medicines
- 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
