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
