Services
Regulatory Affairs
Clinical Research
Medical Affairs
Regulatory Affairs
- Clinical Overviews and Summaries
- Expert statements for renewals, variations etc
- Responding to clinical questions from regulators
- Preparing for, and representation at, regulatory hearings and discussions
- Assessing clinical programmes for regulatory compliance
- Orphan designation applications
- Scientific Advice applications
- Switching legal status
- Writing and reviewing SmPCs and PILs
- SmPC harmonisation
- Pharmacovigilance activities
- Due diligence
- Paediatric Investigation Plans (Pediatric Investigation Plans) and waiver requests
Clinical Research
- Clinical development plans/strategy
- Protocols
- Investigator Brochures
- Interim Medical Advisor
- Clinical trial reports
- Primary papers
- Review papers
- Systematic reviews
- Opinion pieces
- Proceedings
- Congress abstracts, posters and panels
Medical Affairs
- NICE submissions and responses
- Publications planning
- Competitor/market analysis
- Copy approval
- Advisory board set-up and facilitation
- Conference reports
- Speaker presentations
- Slide lecture kits
- Detail aids
- Product monographs
- Sales training materials
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