Regulatory Services
Clinical, Non-Clinical & Post-Approval Services
Clinical, Non-Clinical & Post-Approval Services
- Technical advice and strategies
- Product development advice
- Management of National & European procedures
- Module 1-5 dossier preparation
- Expert Quality, Clinical & Non-Clinical overviews written
- Response to regulatory agency questions
- Investigational Medicinal Product Dossier (IMPD) preparation
- Advanced Therapy Medicinal Products (ATMPs)
- DMF dossier compilation
- DMF critical analysis
- Medical Devices
- PIL User Testing
- Bridging Studies
- Leaflet & SmPC design
- Change of Ownership applications
- Scientific advice meetings
Clinical, Non-Clinical & Post-Approval Services
Clinical, Non-Clinical & Post-Approval Services
Clinical, Non-Clinical & Post-Approval Services
Clinical
- Bioequivalence & clinical study design
- Bioequivalence & clinical study protocol and data review
- Writing of clinical overviews
Non-Clinical
- Toxicological study design
- Toxicological study data review
- Qualification of impurities
- Writing of non-clinical overviews
Post-Approval
- Technical advice and strategies
- Variations preparation
- Renewals preparation
- Management of out of specification batches
- Resolution of product life-cycle issues at manufacturing
Technical Services
Clinical, Non-Clinical & Post-Approval Services
Technical Services
- Pharmacovigilance
- Training – technical and regulatory affairs
- Quality Assurance
- Due Diligence
- Interpretation of guidelines & Directives
- Preparation of guidelines
- Auditing and devising regulatory systems
- Developing products in-line with regulatory guidance
- Tech transfer of products