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
